Barrier system to reduce the rates of infections

ABSTRACT

A barrier system is provided for use in reducing infections associated with post-operative surgical incision and/or a percutaneous medical device, such as a catheter, that is disposed within the surgical incision. Such a barrier system may include: a barrier device having a skin-contacting surface and a catheter-receiving surface; and an adhesive composition configured for adhering to skin, the barrier device, and/or the catheter so as to form a barrier at or adjacent to an incision in the skin where the catheter is percutaneously inserted through the skin. A tensioning anchor and associated system of two or more tensioning anchors is provided for post-operative wound closure. A method for applying and removing the barrier device and tensioning anchors is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 14/610,925, filed Jan. 30, 2015, which is a continuation ofU.S. patent application Ser. No. 12/334,056, filed Dec. 12, 2008, nowU.S. Pat. No. 8,945,062, which claims benefit of U.S. Patent ApplicationSer. No. 61/012,990, filed Dec. 12, 2007, the entireties of which areincorporated herein by reference. This application also claims priorityto and the benefit of U.S. Patent Application Ser. No. 62/189,615, filedJul. 7, 2015 and 62/189,616, filed Jul. 7, 2015, the entireties of whichare incorporated herein by reference.

BACKGROUND

Bacterial wound infections following surgical procedures are a veryserious problem that have long plagued the medical community. Theseinfections commonly result in prolonged hospital stays and increasedcosts. Many of these infections occur during the postoperative period,after the patient leaves the operating room, but before a deep surgicalwound has had time to heal. Adequate closure and prevention ofcontamination of the wound during the first several days post-procedureis key.

Typical surgical wound dressings adhere to the skin with a pressuresensitive adhesive (PSA). Though convenient for bandage removal, thesePSA's do not significantly impede migration of bacteria along the skinsurface. This leaves fresh post-operative wounds particularly vulnerableto gross contamination. In addition, because of their ease of removal,wound dressings adherent to the skin with PSA's are more prone to beingdislodged or “rolled-up” at the edges, leaving a wound exposed.

Securing a wound dressing to the skin with a cyanoacrylate adhesiveimmediately following surgery would provide a superior bacterial barriercompared to standard dressings. Use of cyanoacrylates (or otheradhesives with similar barrier properties) would greatly decrease theability of skin-surface bacteria, in contact with the dressing edges,from migrating freely underneath the dressing. These cyanoacrylateadhesives make accidental dislodgment or “rolling-up” of the dressing,which commonly results from movement in the hospital bed or otheractivities-of-daily living, much less likely, resulting in better woundprotection. Compared to standard PSA's, cured cyanoacrylate polymersthemselves are a far superior microbial barrier, inhibiting migration ofbacteria through the adhesive itself.

Forced removal of any bandage or other device adhered to the skin via acyanoacrylate, or similar polymer, could result in skin injury. Giventhe tremendous bond these adhesives create with skin, thesecyanoacrylates are typically allowed to slough off over time. Thispassive removal method would likely not be acceptable for use insecuring a bandage or other medical device to the skin.

The subject matter claimed herein is not limited to embodiments thatsolve any disadvantages or that operate only in environments such asthose described above. Rather, this background is only provided toillustrate one exemplary technology area where some embodimentsdescribed herein may be practiced.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

In one embodiment, the disclosure includes a barrier device that has atop and bottom surface, a compliant portion, an enclosed inner chamber,an adhesive composition, and a port. The compliant portion may be abladder disposed on the bottom surface of the device. The bladder mayalso be disposed around the perimeter edges of the barrier device andthe inner chamber may reside inside the bladder. The adhesivecomposition may be a cyanoacrylate and the port may be a Luer lockconnection. A pressure sensitive adhesive composition may be disposed onthe bottom surface of the barrier device.

In one embodiment, a barrier device includes an inner chamber enclosedby top and bottom layers of the barrier device. The bottom layer mayhave compliant portions and may have areas of reduced thickness.

In one embodiment, the adhesive composition is encapsulated in aplurality of capsules and disposed on the bottom surface of the barrierdevice. The encapsulated adhesive composition is configured such thatapplying pressure to the capsules causes them to become leaky or tobreak, thus releasing the adhesive composition. In another embodiment ofthe barrier device, the adhesive composition resides in a groove on thebottom surface of the barrier device. A groove seal covers the adhesivecomposition within the groove. The adhesive composition, groove, andgroove seal are configured such that removing the groove seal exposesthe adhesive composition to the air and allows the adhesive compositionto polymerize.

In one embodiment, a barrier device includes an absorbent materialdisposed on the bottom surface of the device and located generallymedial to the adhesive composition. The absorbent material is configuredto absorb excess fluids on the surface.

In one embodiment, the present disclosure includes a method for removinga barrier device that includes injecting a fluid (e.g., liquid or gas)into the inner chamber and expanding the compliant portion of thebarrier device, the expansion weakening the bond between the adhesivecomposition and the barrier device. The barrier device may then bepulled off of the patient without damaging the skin, while portions ofthe adhesive composition may remain on the skin.

In one embodiment, the present disclosure includes a method for applyinga surface barrier device that includes applying the adhesive compositionto the compliant portion of the barrier device and placing the barrierdevice on the skin of a patient. The placement of the barrier device issuch that the adhesive composition residing on the bottom of the barrierdevice creates a sealed barrier around a surgical incision or wound inthe skin. This barrier is situated such that bacteria cannot penetratethe barrier device or make contact with the wound, either by migratingacross the surface of the skin or otherwise finding access to the wound.

In one embodiment of the present disclosure, a wound occlusion kitincludes a barrier device, an adhesive composition, and a syringe orother injector for injecting a fluid. In one embodiment of the presentdisclosure, a wound occlusion kit also includes a surface disinfectingfluid and/or tool.

In one embodiment, the present disclosure includes a wound closuretensioning anchor. The tensioning anchor includes a base member, aconnecting member, a receiving member, an expandable membrane, and aport. In one embodiment, a tensioning anchor may include an adjustmentmechanism that draws the connecting member in towards the anchor orreleases it out away from the anchor. In another embodiment, anadjustment mechanism includes a torque limiting slip clutch. In yetanother embodiment, the tensioning anchor includes a locking mechanismto lock the connecting member and adjustment mechanism in place. In yetanother embodiment, the tensioning anchor may include a force gage toinform a user of the force applied to the skin of a patient by theanchor. In yet another embodiment of a tensioning anchor, the adhesivecomposition may be a cyanoacrylate and the port may be a Luer lockconnection.

In one embodiment of the tensioning anchor, ventilation features areprovided to allow air to flow to the skin where the anchor has beenadhered. In one embodiment, the expandable membrane is disposed on thebottom surface of the base member. In one embodiment, the expandablemembrane is disposed around the perimeter edge of the base member. Inone embodiment, a tensioning anchor includes a pulley mechanism that maybe coupled to the receiving member.

In one embodiment, the present disclosure includes a method fordecreasing the size of an aperture on a patient's skin that includesadhering a first and second anchor to the skin of a patient on opposingsides of the aperture, inserting a connecting member into the receivingmembers of the anchors, adjusting a distance between the anchors, andlocking the connecting member in place. In one embodiment, a method isprovided wherein an adjustment mechanism may be activated to draw in orrelease out the connecting member from one or more of the anchors.

In one embodiment, the present disclosure includes a wound closure kitcomprising a connecting member, an adhesive composition, a syringeand/or other injector for injecting a fluid, and at least three closureanchors. In another embodiment, a wound closure kit includes a surfacedisinfecting fluid and/or tool.

In one embodiment of the present disclosure, a wound closure systemincludes a first and second tensioning anchor, each tensioning anchorconnected to at least one other tensioning anchor via a connectingmember. Each of the anchors of the system comprise a base member, areceiving member, an expandable membrane, and a port. Another embodimentof a wound closure system includes a third anchor that is connected toat least one of a first and second anchor via a connecting member.

Additional features and advantages will be set forth in the descriptionwhich follows, and in part will be obvious from the description, or maybe learned by the practice of the teachings herein. Features andadvantages of the invention may be realized and obtained by means of theinstruments and combinations particularly pointed out in the appendedclaims. Features of the present invention will become more fullyapparent from the following description and appended claims, or may belearned by the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otherfeatures of the disclosure can be obtained, a more particulardescription will be rendered by reference to specific embodimentsthereof which are illustrated in the appended drawings. For betterunderstanding, the like elements have been designated by like referencenumbers throughout the various accompanying figures. While some of thedrawings may be schematic or exaggerated representations of concepts, atleast some of the drawings may be drawn to scale. Understanding that thedrawings depict some example embodiments, the embodiments will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIGS. 1A-1C include various views of an embodiment of a barrier devicein accordance with the present invention.

FIG. 1D includes an illustration of the barrier device of FIGS. 1A-1Cduring use.

FIGS. 2A-2C include various views of an embodiment of a barrier devicein accordance with the present disclosure.

FIG. 2D includes an illustration of the barrier device of FIGS. 2A-2Cduring use.

FIGS. 3A-3C include various views of an embodiment of a barrier devicein accordance with the present disclosure.

FIGS. 4A-4E include various views of an embodiment of a barrier devicethat includes a fastener, and also show different embodiments offasteners for fastening a medical device to the barrier device.

FIGS. 5A-5B include various views of an embodiment of a barrier devicethat includes securement straps.

FIGS. 6A-6C include various views of an embodiment of a barrier devicethat has a medical device-receiving groove in a base surface.

FIGS. 7A-7B include various views of an embodiment of a barrier devicethat includes chilling conduits.

FIGS. 8A-8B include various views of an embodiment of a barrier devicethat includes an expandable bladder.

FIG. 9 includes an embodiment of a barrier device that includes arelease cord.

FIGS. 10A-10C include various views of an embodiment of a modularbarrier device that includes decouplable members that can be separatedby pulling a release wire.

FIGS. 11A-11C include various views of an embodiment of a modularbarrier device that includes decouplable members that can be separatedfrom each other.

FIGS. 12A-12C include various views of an embodiment of a modularbarrier device that includes decouplable members that can be separatedby separation of a perforation.

FIGS. 13A-13B illustrate cross-sectional views of an embodiment of abarrier device including an inflatable bladder disposed on a bottomsurface of the device.

FIG. 13C illustrates a partial cross-sectional view of an embodiment ofa barrier device where a bladder disposed on the bottom surface of thedevice is inflated.

FIG. 14 illustrates a partial cross-sectional view of an embodiment of abarrier device where a bladder disposed at a perimeter edge of thebarrier device is inflated.

FIG. 15A illustrates a cross-sectional view of an embodiment of abarrier device.

FIG. 15B illustrates a cross-sectional view of an embodiment of abarrier device where portions of a bottom layer of the device areexpanded.

FIG. 16A illustrates a top view of an embodiment of a barrier device.

FIG. 16B illustrates a bottom view of an embodiment of a barrier device.

FIG. 17 illustrates a bottom view of an embodiment of a barrier device.

FIGS. 18A-18B illustrate various views of an embodiment of a barrierdevice wherein an adhesive composition is sealed within a groove with aseal.

FIG. 19 illustrates a perspective view of an embodiment of a barrierdevice that includes an encapsulated adhesive composition disposed on abottom surface of the device.

FIG. 20A illustrates a perspective view of an embodiment of a tensioninganchor.

FIGS. 20B-20C illustrate various views of an embodiment of a tensioninganchor wherein an inflated bladder is disposed at a perimeter edge ofthe tensioning anchor.

FIG. 21 illustrates a side view of an embodiment of a tensioning anchor.

FIG. 22A illustrates a partial cross-sectional view of an embodiment ofa tensioning anchor wherein an uninflated bladder is disposed on abottom surface of the tensioning anchor.

FIG. 22B illustrates a partial cross-sectional view of an embodiment ofa tensioning anchor wherein an inflated bladder is disposed on a bottomsurface of the tensioning anchor.

FIGS. 23A-23B illustrate various views of an embodiment of a tensioninganchor wherein a bottom compliant membrane has been inflated.

FIG. 24 illustrates a perspective view of an embodiment of a tensioninganchor that includes an adjustment mechanism.

FIG. 25 illustrates an exploded view of an embodiment of a tensioninganchor that includes an adjustment mechanism and a torque limiting slipclutch.

FIG. 26 illustrates a top view of an embodiment of a wound closuresystem.

FIG. 27 illustrates a top view of an embodiment of a wound closuresystem.

DETAILED DESCRIPTION

The present disclosure includes a barrier device, adhesive composition,system having the device and adhesive, and methods of using the deviceand adhesive that inhibit and/or prevent infections from occurring at orin an insertion site where a medical device (e.g., catheter) penetratesthe skin. In one embodiment of the disclosure, a barrier device that hasbeen secured to the skin with a cyanoacrylate or similar adhesive may beremoved while reducing the occurrence of tissue damage. The presentdisclosure also includes a barrier device, adhesive composition, systemhaving the device and adhesive, and methods of using the device andadhesive that inhibit and/or prevent infections from occurring at anaperture (e.g. surgical incision, wound, or other apertures) on asurface such as the skin of a patient.

For example, the insertion site at an aperture may be from a catheter,needle, or other medical device that is inserted through the skin. Anaperture may be a wound or surgical incision. Also, the barrier deviceand adhesive may be used to affix the medical device at a desiredposition with respect to the insertion site so that the medical devicedoes not move during a medical procedure or during normal patientmovement. Affixing the medical device at or around the insertion site toa barrier device can inhibit microbes from migrating into the insertionsite by inhibiting the inward and outward slippage of the medical device(e.g., a catheter) with respect to the incision (e.g., pistoning). Thus,in at least one embodiment, the barrier device can be applied to skin ator proximal to an insertion site in the skin with the adhesive in orderto inhibit and/or prevent infections from occurring and/or propagatingat the insertion site while also inhibiting microbes from migrating intothe insertion site by inward and outward slippage of the medical device.

The device and adhesive can cooperate so as to provide a mechanicalbarrier on the skin at the insertion site as well as adjacent to theaperture. The design of the device and use of the adhesive can allow forthe formation of one or more barrier points that can inhibit and/orprevent microbes from entering into the aperture and insertion site.Also, the device and adhesive combination can provide one or moreanti-microbial barriers that can inhibit propagation of the microbesthat come into contact with the medical device, skin, or the like. Abarrier point is formed by adhering the barrier device to skin andoptionally adhering the barrier device to the medical device so as toocclude the aperture and/or insertion site. This inhibits microbes fromentering into and infecting the aperture and/or insertion site.

The use of a device and adhesive can provide an impermeable barrieragainst the bacteria that tend to infect catheters by contaminating thecatheter at the site of skin entry and subsequently traveling down theexternal surface of the catheter and into the bloodstream. Importantly,the device and adhesive can be used without the need for many of theantimicrobials and antiseptics that are commonly employed. Such abarrier can eliminate issues of organism resistance that are commonlyassociated with the currently available antimicrobials and antiseptics.Thus, the device and adhesive can be advantageous in limiting the use ofantimicrobials and antiseptics, and thereby reduce the onset oroccurrence of drug resistant microbes.

Current practices try to decrease the incidence of catheter-relatedinfections (CRI) by decreasing the bacterial load through antiseptics orantibiotics. However, CRI can now be inhibited or ameliorated by amethod of using a composition and/or medical device as a barrier at asite where a medical device is inserted into skin. As such, theinventive composition and/or medical device can block access of thecolonizing bacteria to the extraluminal surface of the catheter at theskin-catheter interface. Also, such a method of using the inventivecomposition and/or medical device can be used in addition to currentinfection-reducing interventions.

While the barrier device can be used in a manner that does not requirethe use of an antimicrobial composition, such antimicrobial compositionscan be applied at various locations with respect to the barrier deviceand placement on the skin. For example, the antimicrobial composition,such as a traditional antibiotic or antiseptic (e.g., chlorhexidine,alcohols, quaternary ammonium compounds, boric acid, chlorhexidinegluconate, iodine, etc.) can be manually placed on the skin or apertureprior to placement of the barrier device. Such antimicrobialcompositions may also be maintained within a reservoir within thebarrier device. This can include the antimicrobial composition beingdeposited on a skin-contacting surface, medical device-contactingsurface, or the like.

Primary closure of complex, often large soft tissue defects followingsurgical procedures is a common challenge for surgeons. Primary closureof a post-operative wound refers to the closing of a wound directlyafter the injury occurs. In contrast to wound closure by secondaryintention, primary closure simplifies wound care, allowing the wound toheal more quickly and resulting in a better cosmetic outcome. Inabilityto complete primary closure of a wound results in more wound discomfort,prolonged healing and a larger surgical scar. However, primary closureof wounds under high tension increases the risk for wound dehiscence(i.e. separation of the layers of a surgical wound), a serious surgicalcomplication associated with considerable morbidity and mortality.

Current methods of primary closure of post-operative wounds include theuse of sutures and staples, which can leave unsightly scars and arelimited in the amount of force they can apply to the skin. Therefore, itmay be desirable to have an improved wound closure device and/or methodfor reducing incidences of post-operative wound dehiscence andminimizing scarring. The present disclosure includes a tensioning anchordevice, adhesive composition, system having the anchor device andadhesive, and methods of using the device and adhesive that close anaperture and/or relieves a tension or stress in an aperture on a surfacesuch as the skin of a patient.

I. Barrier Device for Use with Catheters

The barrier device is configured to receive a percutaneous medicaldevice and retain the medical device in a substantially fixed positionwith respect to the percutaneous incision. The barrier device is alsoconfigured to receive an adhesive so as to secure the barrier device tothe skin proximal and/or around the incision, where the barrier devicecan receive the adhesive in one or more locations. The barrier devicecan have various configurations in order to achieve the functionalitiesdescribed herein, which can include providing a barrier againstcontaminants and microbes as well as holding and retaining the medicaldevice in a substantially fixed position such that the medical devicedoes not move into and/or out of the incision during a medicalprocedure. This can prevent the slight wiggles or repositioning of themedical device that may lead to bacteria entering into the incision.

Additionally, the barrier device can be used to prevent movement of themedical device with respect to the incision during typical patientmovement. In many instances, a medical device, such as a pin or rod usedfor bone alignment, can percutaneously extend through the skin for anextended duration of healing. During this time, the patient is likely tobe ambulatory, which in itself can cause the medical device to shift ormove into and/or out from the incision. The barrier device of thepresent disclosure can be utilized for such extended treatments toinhibit or prevent the medical device from moving in or out of theincision.

The barrier device can include a conduit or groove for receiving themedical device. In the instance of a conduit, the medical device can beslid through the conduit or groove before, during, or after insertionthrough the incision. In the instance of a groove, the barrier devicecan be applied or snapped onto the medical device after insertionthrough the incision; however, the barrier device can also be applied orsnapped onto the medical device before or during placement into theincision. In another aspect, the barrier device can have an open (e.g.,open clam) and closed position (e.g., closed clam), where the openedposition allows for the medical device to be passed into an openedconduit before, during, or after insertion into the incision, and thebarrier device can then be closed and sealed to provide a closedconduit. After the medical device and barrier device are properly placedas desired or needed, the adhesive can be applied to selected positionsof the barrier device so as to adhere the barrier device to the skinand/or medical device. Optionally, the adhesive can be applied to theskin at or around the incision before placement of the barrier device,or applied to the barrier device base before being placed on the skin.

The combination of the barrier device and adhesive can be configured soas to assist in maintaining the medical device (e.g., catheter) in astable position with respect to the skin and incision, as well asproviding a barrier to microbes to inhibit and/or prevent infectionsrelated to the percutaneous medical device. Besides catheters, themedical device can be any needle, external fixator pins (used tostabilize fractures of extremities that stick into bone and come outthrough the skin to an external stabilizing device) “K-wires” (smallwires they typically run through finger joints to prevent severe skincontractures, after a burn, from permanently decreasing the range ofmotion of the fingers; these wires go through bone then exit the skin),and any other percutaneous medical device.

FIGS. 1A-1D provide an illustration of an embodiment of a barrier device10. FIG. 1A shows that the barrier device 10 is formed from a body 12that has a first end 14 with a first opening 16 that is opposite from asecond end 18 with a second opening 20. The first opening 16 is in fluidcommunication with the second opening 20 via a substantially straightconduit 22. The body 12 is illustrated to have a tapered cross-sectionalprofile 28 from the first end 14 to the second end 18. However, the body12 can have any shape that can provide the barrier/retention propertiesas described herein. As shown, the first end 14 has a smallercross-sectional profile 28 compared to the second end 18. Accordingly,the second end 18 can include a base 24 that is configured for placementonto skin 40 such that the conduit 22 is aligned with a percutaneousincision 46. Also, the second end 18 is shown to have a flared portion26 that provides stability to the device 10 during use. The taperedcross-sectional profile 28 can be tapered at a constant rate, or flaredas illustrated.

FIG. 1B shows a top view of the barrier device 10, which shows thecross-sectional profile 28 of the body 12 is substantially circular.However, the cross-sectional profile 28 can be any other possible shape,such as triangle, square, rectangle, pentagon, polygon, combinationsthereof, and the like. Also, the cross-sectional profile 28 can changeshapes from one portion to another portion of the device 10. The firstopening 16 can include a taper 30 that narrows into the conduit 22 sothat a medical device 48 is easily received therein.

While the body 12 can have a solid circular cross-sectional profile 28and a closed conduit 22, the body 12 can optionally include a separatingslit 32 extending from the first opening 16 to the second opening 20 sothat the device 10 can open like a clam. By including a separating slit32, the device 10 can be applied to a medical device 48 that is alreadyinserted through a percutaneous incision. The configuration of the slit32 can vary. For example, the slit 32 can include a cooperatingjunction, blunt end junction, matting junction, or the like. Theadhesive that forms the barrier or other adhesive can be used to coupleor integrate the sides of the slit 32 together.

FIG. 1C shows a cutaway side view of the barrier device 10. This viewshows the thickness of the body 12 with respect to the cross-sectionalprofile 28 at various locations along the device 10 or conduit. Thefirst end 14 is shown to have first opening 16 that communicates withthe conduit 22. The first opening 16 can include a taper 30 that narrowsto the conduit 22 so that a medical device 48 can be passed therethroughand into the conduit 22 with ease. The conduit 22 can have asubstantially uniform cross-sectional profile as shown by 22 b, or theconduit 22 can have a tapered conduit as shown by 22 a. While not shown,the conduit 22 can also have a widening conduit that is wider at thefirst opening 16 compared to the second opening 20. The thickness of thebody 12 is dependent on the overall shape of the body 12 as well as theshape of the conduit 22.

The first end 14 is shown to have a thicker body portion at the lip 34of the first opening 16. The lip 34 can provide increased structuralintegrity so that the barrier device 10 does not crack, split, orotherwise break during use or when the medical device 48 traversesthrough the conduit 22.

At the second end 18, the base 24 is shown to have a substantial surfacearea for contacting with the skin 40. This can provide the base 24 withsubstantial stability in contacting the skin and being retained inplace, as desired or needed.

The conduit 22, while being uniform (22 b) or tapered (22 a) can alsoinclude recesses 36 or the like that can be used as reservoirs for theadhesive and/or an antimicrobial composition. The adhesive can beapplied to the recess 36 so that the medical device can be adhered to aconduit surface 38. Also, the second opening 20 can include an expandedarea, which can be formed from a tapered surface when entering theconduit 22 from the second opening 20. The expanded area can beconfigured for receiving adhesive in a location adjacent to the skin 40so as to adhere the skin 40 to the medical device 48 and barrier 10 atlocations around or adjacent to the incision 46.

FIG. 1D shows a cutaway side view of the device 10 illustrated in FIGS.1A-1C during use. The device 10 is applied to the skin 40 and adheredthereto by having adhesive 42 applied to a portion, annular area, orentire base 24 of the device 10. Also, the adhesive 42 a can be appliedto the perimeter 44 of the base 24 to form an outer seal (42 a). Thedevice 10 is adhered to the skin 40 such that the conduit 22 is alignedwith a percutaneous incision 46 that extends into tissue under the skin40. This allows a medical device 48 (e.g., catheter) to be placed in theconduit 22 and into the incision 46.

Optionally, adhesive 42 can be placed in the conduit 22 to form aconduit seal 42 b, on the first opening 16 to form a first opening seal42 c, on the second opening 20 to form a second opening seal 42 d, orthe like. The adhesive 42 can be applied to any location on the device10 that is in contact with skin 40 and/or the medical device 48.

FIGS. 2A-2D illustrate another embodiment of a barrier device 50 thathas many features in common with the barrier device 10 of FIGS. 1A-1D.The barrier device 50 is formed from a body 52 that has a base member 54with a base opening 56 that is coupled to an elongate, bent tube 58 witha tube opening 60. The base opening 56 is in fluid communication withthe tube opening 60 via a bent conduit 62. As shown, the base member 54has a substantially constant cross-sectional profile 68, and is coupledto the tube 58, which has a varying cross-sectional profile 68. The basemember 54 and the tube 58 can be a uniform member or two separatemembers that are coupled together. The base member 54 can include a basesurface 64 that is configured for placement onto skin such that theconduit 62 is aligned with a percutaneous incision 46.

FIG. 2B shows a top view of the barrier device 50, which shows thecross-sectional profile 68 of the body 52 is substantially circular.However, the cross-sectional profile 68 can be any other possible shape,such as triangle, square, rectangle, pentagon, polygon, combinationsthereof, and the like. The tube 58 is shown to be positioned such thatthe tube opening 60 is directed laterally from the base member 54. Also,the tube 58 is shown to include a circumferential groove 70 that isconfigured to receive a fastener member (not shown) of a medical device.For example, the medical device can include an annular protrusion thataligns with the groove 70 so at to mate and fasten the device 50 withthe medical device. Alternative, the groove 70 can receive a restrictingmember (not shown) such as an o-ring, suture, or the like that cancontract and constrict the tube 58 so that the conduit 62 grabs themedical device so inhibit movement therebetween. In another alternative,the groove 70 can be used to receive adhesive so as to form a seal atthe tube opening 60 with the medical device 48. Also, the groove 70 canbe used to receive a suture to increase security of the medical devicewith respect to the barrier device 50.

While the tube end 72 is shown to terminate before reaching the outerperimeter 74 of the base member 54, the tube end 72 can extend past orbe the terminate at the outer perimeter 74 of the base member 54. Thebase member 54 and tube 58 can include a openable slit (not shown) suchthat the device 50 can open up like a clam in order to receive themedical device into the conduit 62.

FIG. 2C shows a cutaway side view of the barrier device 50. This viewshows the thickness of the body 52 with respect to the cross-sectionalprofile 68 at various locations along the device 50 or conduit 62. Thebase member 54 is shown to have base opening 56 that communicates withthe conduit 62. The base opening 56 is shown to have an offset openingthat is at an angle alpha with respect to the base surface 64, whichwould also be at an angle with respect to the skin 40 and tube 58. Theconduit 62 can have a substantially uniform cross-sectional profile 68,or the conduit 62 can have a tapered conduit, or a shape that conformswith the external surface 66 of the device 10. The thickness of the body52 is dependent on the overall shape of the body 52 as well as the shapeof the conduit 62.

The base surface 64 is shown to have a substantial surface area forcontacting with the skin 40. This can provide the base member 54 withsubstantial stability in contacting the skin 40 and being retained inplace, as desired or needed.

While not shown, the conduit 62 can include recesses, expanded openings,or the like that can be used as reservoirs for the adhesive. Theadhesive can be applied to the recess so that the medical device can beadhered to a conduit surface 76. The base member 54 and/or body 52 canalso include recesses to be used as reservoirs for receiving theadhesive and affixation to the skin.

FIG. 2D shows a cutaway side view of the device 50 illustrated in FIGS.2A-2C during use. The device 50 is applied to the skin 40 and adheredthereto by having adhesive 82 applied to a portion, annular area, orentire base 64 of the device 50. Also, the adhesive 82 a can be appliedto the perimeter 74 of the base 54 to form an outer seal (82 a). Thedevice 50 is adhered to the skin 40 such that the conduit 62 is alignedwith a percutaneous incision 46 that extends into tissue under the skin40. This allows a medical device 48 (e.g., catheter) to be placed in theconduit 62 and into the incision 46.

Optionally, adhesive 82 can be placed in the conduit 62 to form aconduit seal 82 b, on the base opening 56 to form a base opening seal 82c, on the tube opening 60 to form a tube opening seal 82 d, or the like.The adhesive 42 can be applied to any location on the device 50 that isin contact with skin 40 and/or the medical device 48.

FIGS. 3A-3C illustrate another embodiment of a barrier device 100 thathas many features in common with the barrier device 10 of FIGS. 1A-1D ordevice 50 of FIGS. 2A-2D. The barrier device 100 is formed from a body102 that has a base member 104 with a base opening 106 that is coupledto a top member 108 with a top opening 110. The base opening 106 is influid communication with the top opening 110 via a conduit 112. Asshown, the base member 104 has a substantially constant cross-sectionalprofile 116, and is coupled to the top member 108, which can have anycross-sectional profile 118. The base member 104 and the top member 108can be a uniform member or two separate members that are coupledtogether. The base member 104 can include a base surface 114 that isconfigured for placement onto skin 40 such that the conduit 112 isaligned with a percutaneous incision 46.

FIG. 3B shows a top view of the barrier device 100, which shows thecross-sectional profile 116 of the base member 104 is substantiallyrectangular. However, the cross-sectional profile can be any otherpossible shape, such as triangle, square, circle, pentagon, polygon,combinations thereof, and the like. Similarly, the cross-sectionalprofile 118 of the top member 108 can be any shape, such as thosedescribed. The top member 108 is shown to be positioned such that thetop opening 110 is directed laterally from the base member 104. Also,the top member 108 is shown to include a concave face 120, however, theface 120 can be blunt, convex or the like. The concave face 120 can aidin inserting the medical device into the conduit 112.

While the face 120 of the top member 108 is shown to terminate beforereaching the outer perimeter 122 of the base member 104, the face 120can extend past or be the terminate at the outer perimeter 122 of thebase member 104. The base member 104 and top member 108 can include aopenable slit (not shown) such that the device 100 can open and closelike a clam in order to receive the medical device into the conduit 112.

FIG. 3C shows a cutaway side view of the barrier device 100 in use. Thisview shows the thickness of the body 102 with respect to thecross-sectional profile 116, 118 at various locations along the device100 or conduit 112. The base member 104 is shown to have base opening106 that communicates with the conduit 112. The base opening 106 isshown to have an offset opening that is at an angle alpha with respectto the base surface 114, which would also be at an angle with respect tothe skin 40 and top member 108. The conduit 112 can have a substantiallyuniform cross-sectional profile, or the conduit 112 can have a taperedprofile, or a shape that conforms with the external surface 124 of thedevice 10. The thickness of the body 102 is dependent on the overallshape of the body 102 as well as the shape of the conduit 112.

The base surface 114 is shown to have a substantial surface area forcontacting with the skin 40. This can provide the base member 104 withsubstantial stability in contacting the skin 40 and being retained inplace, as desired or needed. However, a base surface 114 having aminimal surface area could also be used to provide a barrier.

While not shown, the conduit 112 can include recesses, expandedopenings, or the like that can be used as reservoirs for the adhesive.The adhesive can be applied to the recess so that the medical device canbe adhered to a conduit surface 126.

The device 100 is applied to the skin 40 and adhered thereto by havingadhesive 130 applied to a portion, annular area, or entire base surface114 of the device 100. Also, the adhesive 130 a can be applied to theperimeter 122 of the base 104 to form an outer seal (130 a). The device100 is adhered to the skin 40 such that the conduit 112 is aligned witha percutaneous incision 46 that extends into tissue under the skin 40.This allows a medical device 48 (e.g., catheter) to be placed in theconduit 112 and into the incision 46.

Optionally, adhesive 130 can be placed in the conduit 112 to form aconduit seal 130 b, on the base opening 106 to form a base opening seal130 c, on the top opening 110 to form a top opening seal 130 d, or thelike. The adhesive 130 can be applied to any location on the device 100that is in contact with skin 40 and/or the medical device 48.

FIGS. 4A-4B illustrate another embodiment of a barrier device 150 thathas many features in common with the barrier device 10 of FIGS. 1A-1D,device 50 of FIGS. 2A-2D, and device 100 of FIGS. 3A-3C. As illustrated,the barrier device 150 is configured substantially the same as thedevice of FIGS. 3A-3C; however, the features of FIGS. 4A-4B can also beapplied to any barrier device described herein, and vice versa. Thebarrier device 150 is shown to include a fastener 152 that fastens themedical device 48 to the barrier device 150. The fastener 152 isadvantageous in retaining the tube of the medical device 48 against thebarrier device 150, which can aid in the retention and barrierproperties of the device 150. Briefly, the barrier device 150 is formedfrom a body 153 that has a base member 154 with a base opening 156 thatis coupled to a top member 158 with a top opening 160. The base opening156 is in fluid communication with the top opening 160 via a conduit162.

The fastener 152 is disposed on the base member 154 in a position thatallows for receiving the medical device 48. The fastener 152 isconfigured similarly to a “C” clamp that can be manually opened by handto receive the medical device 48. For example, the medical device 48 canbe snapped into the fastener 152 so as to be received into the fastenerreceiver 164. The medical device 48 can then be removed from thefastener 152 by snapping the medical device 48 from the receiver 164,which can be done by hand.

While the fastener 152 is shown to be in a “C” clamp configuration inFIG. 4A-4C, other types of fasteners can be employed, which can includea conduit fastener 166 (FIG. 4D), half fastener 168 (FIG. 4E), or thelike. In fact, any suitable type of fastening system, such as those thatare removable, releasable, flexible, elastic, and the like can be usedwith the barrier device.

FIGS. 5A-5B illustrate another embodiment of a barrier device 200 thathas many features in common with the device 50 of FIGS. 2A-2D. However,the features of FIGS. 5A-5B can also be applied to any barrier devicedescribed herein, and vice versa. As shown, the barrier device includesa base 202 configured as described herein. The base 202 includes one ormore fastener straps 204 that extend from the base 202 so as to bedisposed over the skin 40 when applied to a subject. The device 200 isshown to have two fastener straps 204; however, more or less straps 204can be used. Each strap 204 can include a body 206 that has a terminalhead 208 that can be disposed on the skin 40. the body 206 can beconnected to the base 202 at a connection point 210, which can be rigid,flexible, stretchable, or the like. The strap 204 can be prepared from auniform material with the base 202, or can be two separate members thatare coupled together. The head 208 can be solid or have a hole 212. Thehead 208 can be configured for being affixed to the skin 40 in a fixedor removable manner. For example, the head 208 can be glued to the skin40 with adhesive 214 (as shown) or sutured to the skin 40 with sutures(not shown). Other means of affixation can also be used. The straps 204can improve the retention of the barrier device 200 to the skin 40.While the straps 204 are shown to have a defined shape, other shapes andconfigurations can be used so at to increase the retention of thebarrier device 200 on the skin 40 so that it does not move during themedical procedure.

The barrier device can be prepared from any medically acceptablematerial. That is, any material that is used for a medical device,ranging from catheters to bandages, can be used in preparing a boot asdescribed and shown herein. For example, the boot, which can be invarious shapes and sizes, can be prepared from rubbers, elastomers,bandage-like materials, cloth, fibrous materials, paper, porousmaterials, plastics, hard plastics, maleable plastics, polyethylenes,polystyrenes, foams, memory foams, polyurethanes, latexes, and the like.

In one embodiment, the barrier device does not have an aperture orclosed conduit, but can be configured to lay over a percutaneous medicaldevice. The barrier device can have a receiving surface or recess thatcan receive the medical device. For example, the recess can be asemi-circular conduit that lays over the medical device and on the skin.As such, the barrier device can have a medical device receiving surface,groove, recess, or the like that can be flat, flexible, bendable,malleable, grooved so as to receive a catheter, and the like.

FIGS. 6A-6B show an embodiment of a barrier device 250 that includes abody 252 having a recess 254 configured for receiving a medical device48. The recess 254 can have a closed end 256 that is located within thebody 252. The closed end 256 can be configured for receiving the portionof the medical device 48 that protrudes from the percutaneous incision46 in the skin 40. At the other end of the recess 254 is an open end 256that opens from the device 250 so that the medical device can extendpast the perimeter 260 of the device 250. The adhesive (not shown) canbe applied to any portion of the device as described herein, includingat any point on the recess 254 or perimeter 260 or base 262 of the body252.

As shown in FIGS. 7A-7B, an embodiment of a barrier device 270 caninclude one or more chilling conduits 272 formed in the portion of thebody 274 that contacts the skin. The chilling conduits 272 can be thesame or different from the conduits described herein for receiving themedical device. The chilling conduits 272 are configured for receiving achilled fluid that can be applied through the conduits 272 so as toprovide the chilled fluid to the adhesive 276. Chilling can cause theadhesive 276 to become brittle and easily broken and/or separated fromthe skin. Suitable chilling fluids can include dimethyl ether, propane,liquid nitrogen, tetrafluoroethane, and the like. The use of chillingfluids can aid in removal of the device 270 when it is time to removethe medical device from the incision.

While chilling conduits are illustrated, such chilling conduits can bepresent in various sizes and configurations. The chilling conduit can beat any of the following: at a perimeter edge of the barrier device;around the perimeter of the barrier device; at the base of the barrierdevice; around the medical device conduit; around the top opening fromwhich the medical device protrudes; in fluid communication with themedical device conduit; a conduit in communication with one or more ofthe foregoing conduits; combinations thereof; and the like.Additionally, components for introducing a chilling fluid into thechilling conduits can be included in the present disclosure, such asreservoirs of chilling fluids, tubing, tube fittings, syringes, and thelike.

In one embodiment, the conduits, such as chilling conduit or medicaldevice conduit, can include linings. As such, another material such as apolymer, metal, alloy, ceramic, fiberglass, or the like can be coatedalong the surface of the conduit to provide various properties. Suchlinings can be advantageous in providing structural integrity or forincreasing the heat (cold) transfer characteristics for more rapidtemperature changes.

In one embodiment, the chilling conduit can be filled within anothermaterial to change the properties of the barrier device. For example,the conduits can be filled with other polymers, metals, alloys,fiberglass, fiber optics, or the like. A metal-filled conduit can beused to provide cooler temperatures to the adhesives located on theother end of the conduit to increase the cooling of the adhesive. Metalconduits can also be used to propagate electricity across the adhesiveto degrade adhesives that are subject to degradation when exposed toelectrical currents. Also, a fiber optic-filled conduit, or otherwave-guide or wave carrier, can be useful when the adhesive is subjectto degradation upon receiving laser light or other energetic waves thatcan weaken the adhesive.

As shown in FIGS. 8A-8B, an embodiment of a barrier device 280 caninclude one or more expandable bladders 284 at locations on the body 282of the barrier device 280 that contact the skin. During use, thebladders 284 can be in unexpanded states, and when the it is time forthe medical device to be withdrawn, the bladders 284 can be expanded.Such an expansion can break the seal of the adhesive 286 so that thebarrier device 280 can be easily removed from the skin. For example, thebladder 284 can be disposed on the base surface 288 of the body 282.While not shown, the body can also include conduits for passing gassesto the bladder 284 to enable inflation. Also, hypodermic needles or thelike can be used to supply gasses to the bladder 284 to effectexpansion.

FIG. 9 illustrates an embodiment of a barrier device 290 that caninclude a release cord 292. While shown to be located at the outerperimeter 294 of the device 290, the release cord 292 can be disposedanywhere on the device 290 that contacts the skin. For example, therelease cord 292 can be in a coil formation 296 that coils along thebase surface of the device. When it is time to remove the medical devicefrom the incision, the release cord 292 can be pulled so as to break theseal and barrier between the barrier device 290 and the skin.

FIGS. 10A-10C illustrate an embodiment of a modular barrier device 300.The modular barrier device 300 can include a main barrier 302 and aperimeter barrier 304. The main barrier 302 can be configured as anybarrier device as described herein. The perimeter barrier 304 is sizedso as to be coupled/couplable to the perimeter surface 306 of the mainbarrier 302. For example, the perimeter barrier 304 can include an outerperimeter surface 308 and an inner perimeter surface 310 that is shapedand sized to conform with the perimeter surface 306 of the main barrier302. When the main barrier 302 and perimeter barrier 304 are placedtogether so as to form the modular barrier device 300, the perimetersurface 306 forms a gap 311 with the inner perimeter surface 310 of theperimeter barrier 304. A wire 312 can be imbedded on, within, at, oradjacent to the gap 311, such that pulling the wire 312 allows for themain barrier 302 to be decoupled from the perimeter barrier 304. Asshown, the wire 312 is disposed within a wire recess 320 that extendsaround inner perimeter surface 310 of the perimeter barrier 304;however, the wire 312 and wire recess 320 can be in or at the gap 311 aswell as within the main barrier 302 proximal or adjacent to theperimeter surface 306 of the main barrier 302.

FIG. 10B illustrates the modular barrier device 300 as applied to skin(not shown) with adhesive 318. The main barrier 302 includes a main basesurface 314 that is shown to be disposed on the skin without adhesive;however, adhesive can be applied to the main base surface 314. Theperimeter device 304 includes a perimeter base surface 316 which isshown to be affixed to the skin with adhesive 318. The adhesive 318 isshown to be on the perimeter base surface 316, outer perimeter surface308 and over the gap 311.

FIG. 10C illustrates the modular barrier device 300 being removed fromthe skin. As shown, the wire 312 is pulled from the wire recess 320 soas to cut, disrupt, separate, or otherwise remove the adhesive 318 fromthe device 300. This includes cutting the adhesive 318 adjacent to thewire recess 320 and/or gap 311 so that main barrier 302 can be separatedfrom the perimeter barrier 304 and pulled from the skin.

FIGS. 11A-11C illustrate another embodiment of a modular barrier device350. The modular barrier device 350 can include a main barrier 352 and aperimeter barrier 354. The main barrier 352 can be configured as anybarrier device as described herein. The perimeter barrier 354 is sizedso as to be coupled/couplable to the perimeter surface 356 of the mainbarrier 352. For example, the perimeter barrier 354 can include an outerperimeter surface 358 and an inner perimeter surface 360 that is shapedand sized to conform with the perimeter surface 356 of the main barrier352. When the main barrier 352 and perimeter barrier 354 are placedtogether so as to form the modular barrier device 350, the perimetersurface 356 forms a gap 361 with the inner perimeter surface 360 of theperimeter barrier 354. A release member 362, such as a wire, membrane,zip-lock members, or the like, can be imbedded on, within, at, oradjacent to the gap 361, such that pulling the release member 362 allowsfor the main barrier 352 to be decoupled from the perimeter barrier 354.As shown, the release member 362 is disposed within a junction 365 thatextends around inner perimeter surface 360 of the perimeter barrier 354;however, the release member 362 and junction 365 can be in or at the gap361 as well as within the main barrier 352 proximal or adjacent to theperimeter surface 356 of the main barrier 352. A cover member 364 can bedisposed over or integrated with the release member 362 and junction 365so as to keep the release member 360 disposed at the junction 365. Thecover member 364 can be a material that is slit, cut, removed, lifted,or otherwise compromised such that pulling the release member 362removes the cover member 364 and exposes junction 365 and gap 361. Asshown, the cover member 364 is disposed over the perimeter surface 356of the main barrier and inner perimeter surface 360 of the perimeterbarrier 354.

FIG. 11B illustrates the modular barrier device 350 as applied to skin(not shown) with adhesive 366. The main barrier 352 includes a main basesurface 368 that is shown to be disposed on the skin without adhesive;however, adhesive can be applied to the main base surface 368. Theperimeter device 354 includes a perimeter base surface 370 which isshown to be affixed to the skin with adhesive 366. The adhesive 366 isshown to be on the perimeter base surface 370, outer perimeter surface358 and over the gap 361.

FIG. 11C illustrates the modular barrier device 350 being removed fromthe skin. As shown, the release member 362 is pulled from the junction365 so as to lift/detach the cover member 364 from the main barrier 352and perimeter barrier 354 so as to cut, disrupt, separate, or otherwiseremove the adhesive 366 from the device 350. This can expose thejunction 365 and/or gap 311 so that main barrier 302 can be separatedfrom the perimeter barrier 304 and pulled from the skin. For example,the release member can be configured similar to a zip lock, orreleaseable cellophane membrane.

FIGS. 12A-12C illustrate an embodiment of a perforated barrier device400. The perforated barrier device 400 has a perforation 406 that can beused to separate the main barrier 402 from a perimeter portion 404. Theperforated barrier device 400 optionally may includes a rip member 408that can be pulled to separate the main barrier 402 from the perimeterportion 404. The rip member 408 can be member that is pulled to splitthe perforation 406 or it can be an integrated member that separates atthe perforation 406 when it is pulled from the device 400. Rip members408 and perforation 406 are often found in food storage bags where themember can be ripped to open the bag.

FIG. 12B illustrates the perforated barrier device 400 as applied toskin (not shown) with adhesive 410. The main barrier 402 includes a mainbase surface 412 that is shown to be disposed on the skin withoutadhesive; however, adhesive can be applied to the main base surface 412.The perimeter portion 404 includes a perimeter base surface 414 which isshown to be affixed to the skin with adhesive 410. The perforation 406is shown to include a rip member 408 that is coupled to the main barrier402 and perimeter portion 404 such that removal or ripping of the ripmember 408 opens the perforation 406. The perforation 406 also includesa plurality of perforation recesses 409 that allow for the rip member408 to be easily removed. The perforation recesses 409 can be holes orany other perforation configuration.

In one embodiment, the barrier devices as described herein can beprepared as a series of nested barrier devices. This can include morethan one barrier device being used in a series. Also, when configured asnested barrier devices, an antimicrobial composition can be disposedbetween the nested barrier devices or on any surface of the nestedbarrier devices.

The barrier devices as shown and described herein can include variousfeatures or configurations of any of the other barrier devices. As such,a feature or configuration of one depicted barrier device can beincluded on another embodiment of a barrier device that is shown in adifferent figure. Thus, the features of the barrier devices areinterchangeable and can be used together as desired.

II. Aperture Barrier Device

It will be understood that one or more components or features of theembodiments of barrier devices disclosed herein may be combined with oneor more other embodiments of barrier devices disclosed herein.

Referring generally to FIG. 13A-C, FIG. 13A illustrates an embodiment ofa barrier device 1301 that includes one or more expandable bladders1302. In the illustrated embodiment, the bladder 1302 is shown to bedisposed on a bottom surface 1305 of the barrier device 1301. As shown,the bladder 1302 may be positioned adjacent to and/or around a perimeteredge 1306 of the barrier device 1301. In other embodiments, the bladder1302 may be disposed further away from the perimeter edge 1306 on thebottom surface 1305 of the barrier device 1301.

In one embodiment, the bladder 1302 may be disposed at the perimeteredge 1306, as shown in FIG. 13C. In various embodiments, the distance ofthe bladder 1302 from the perimeter edge 1306 on the bottom surface 1305may vary. For example, a bladder 1302 may extend about the barrierdevice 1301 while the bladder 1302 may vary in location with respect tothe perimeter edge 1306 about a perimeter of the barrier device 1301. Inother words, a bladder 1302 may be disposed at the perimeter edge 1306for at least a portion of the perimeter of the barrier device 1301, maybe disposed on the bottom surface 1305 of the barrier device 1301adjacent the perimeter edge 1306 for at least a portion of the perimeterof the barrier device 1301, may be disposed on the bottom surface 1305of the barrier device 1301 offset from the perimeter edge 1306 for atleast a portion of the perimeter of the barrier device 1301, may beotherwise located, or combinations thereof.

Also, multiple bladders 1302 may be disposed on the barrier device 1301.For example, a first bladder 1302 may be disposed at the perimeter edge1306 of the barrier device 1301 and a second bladder 1302 may bedisposed on the bottom surface 1305 adjacent to the perimeter edge 1306.Also, for example, a first bladder 1302 may be disposed on the bottomsurface 1305 adjacent to the perimeter edge 1306 and a second bladder1302 may be disposed on the bottom surface 1305 further away from theperimeter edge 1306. In one embodiment, the first bladder 1302 mayextend about the perimeter edge 1306 for only a portion of the perimeterof the barrier device 1301 and the second bladder 1302 may be disposedon the bottom surface 1305 and extend about the remaining portion of theperimeter of the barrier device 1301. Thus, a first bladder 1302 mayextend around the entire perimeter of the barrier device 1301 at a firstlocation, the first bladder 1302 may extend around a first portion ofthe perimeter of the barrier device 1301 at the first location, a secondbladder 1302 may extend around the entire perimeter of the barrierdevice 1301 at a second location, the second bladder 1302 may extendaround a second portion of the barrier device 1301 at the secondlocation, or combinations thereof, where the first portion and thesecond portions may at least partially abut, at least partially overlap,or combinations thereof. In some embodiments of a barrier device 1301,one or more bladders 1302 may be disposed in such a way so that abarrier (e.g., completely enclosed) is created around an aperture 2(e.g., a surgical cut, a wound, or other apertures).

In one embodiment, the bladder 1302 may vary along its length. Forexample, the bladder 1302 may vary in cross sectional shape, wallthickness, size, or combinations thereof. In some embodiments, thebladder 1302 may be manufactured separately from the barrier device 1301and subsequently fixed to the barrier device 1301. In some embodiments,the bladder 1302 may be manufactured and/or molded in conjunction withthe barrier device 1301 as a single piece.

An adhesive composition 1303 may adhere the barrier device to the skin 1of a patient. For example, the adhesive composition 1303 may be appliedto a surface of the bladder 1302 (e.g., a bottom-most surface) and thebarrier device 1301 may be placed on the skin 1 of a patient to cover anaperture 2 (e.g., a surgical opening, a wound, or other aperture). Inone embodiment, shown in FIG. 13A, the adhesive composition 1303 hasbeen applied only to the bladder 1302 so that only the bladder 1302binds to the skin 1. In one embodiment, the adhesive composition 1303may be first applied to the bladder 1302 and subsequently adhered to theskin 1. In another embodiment of the barrier device 1301, the adhesivecomposition 1303 may first be applied directly to the skin 1 of apatient. For example, the adhesive composition 1303 may first be appliedto the skin 1 of a patient around an aperture 2 and the barrier device1301 may then be placed onto the skin 1 so that the bladder 1302 makescontact with the adhesive composition 1303 on the skin 1. In yet anotherembodiment, the bladder 1302 may be separate from the barrier device1301. In this embodiment, the bladder 1302 may first be adhered to theskin 1, and the barrier device 1301 may subsequently be adhered to thebladder 1302. The adhesive composition 1303 may include one or moreadhesive compositions described herein.

The bladder 1302 of the embodiment illustrated in FIG. 13A is shown asbeing deflated. The bladder 1302 may remain deflated until the barrierdevice 1301 is to be removed from the skin 1. A fluid (e.g., liquid orgas) may be injected into an inner chamber 1307 (shown in FIG. 13C) ofthe bladder 1302 through a port to at least partially inflate thebladder 1302. Examples of fluids may include saline, water, polyethyleneglycol, atmospheric air, nitrogen, xenon, self-expanding foam,liquid-particulate mixtures, or other biocompatible, medically suitablefluids. Partially inflating the bladder 1302 may facilitate removal ofthe barrier device 1301, as described herein.

A port is not shown in FIGS. 13A-14, but may include, for example, apuncture hole from a hypodermic needle or other fluid injector. In theembodiments of the barrier device 1301 illustrated in FIGS. 13A-14, theinner chambers 1307 of multiple bladders 1302 may each be accessed by asingle port. In other embodiments, each inner chamber 1307 of one ormore bladders 1302 may be accessed independently by multiple ports.Other embodiments of ports are illustrated in FIGS. 15A-16A anddescribed in more detail below.

Inflation of the bladder 1302 increases the surface area of the bladder1302. This expansion may create a stress at an interface 1308 betweenthe bladder 1302 and the adhesive composition 1303 as the adhesivecomposition 1303 may not expand as much as the bladder 1302. Theexpansion of the bladder 1302 may weaken a bond between the bladder 1302and the adhesive composition 1303.

FIGS. 22A and 22B are illustrative of how inflating the bladder 2202weakens the bond between the bladder 2202 and the adhesive composition2203. FIG. 22A illustrates an embodiment of a bladder 2202 similar tothe bladder 1302 illustrated in FIG. 13B, but where the bladder 2202 hasbeen deflated. The interface 2208 (e.g., area where the bladder 2202 andthe adhesive composition abut) between the bladder 2202 and the adhesivecomposition 2203 is greater than the interface 2208 between an inflatedbladder 2202 and the adhesive composition 2203, such as the interface2208 shown in FIG. 22B. In other words, the surface area of the bladder2202 that is in contact with the adhesive composition 2203 is greater inFIG. 22A than it is in FIG. 22B. Also, the circumference of the bladder2202 is greater when inflated, as illustrated in FIG. 22B. Therefore, aninflated bladder 1302 puts a stress at the bladder-adhesive interface1308 by increasing the perimeter of the bladder 1302, while the adhesivecomposition 1303 may be more resistant to expansion. This stress at thebladder-adhesive interface 1308 results in portions of the bladder 1302breaking free from portions of the adhesive composition 1303. As aresult, the surface area of the bladder 1302, which is bonded to theadhesive composition 1303, may be reduced when inflated.

In one embodiment, the inflated bladder 1302 may completely detach fromthe adhesive composition 1303. In another embodiment, the inflatedbladder 1302 may only partially detach from the adhesive composition1303. In one embodiment, once the bond between the bladder 1302 and theadhesive composition 1303 has been weakened, the barrier device 1301 maybe more easily removed, while reducing the incidences of injury to theskin 1. For example, with a reduced interface 1308, forces applied bythe bladder 1302 to the adhesive composition 1303 may be smaller thanforces applied by the skin 1 to the adhesive composition 1303. Thus, theadhesive composition 1303 may remain on the skin 1 rather than thebladder 1302. In one embodiment, portions of the bladder 1302 may tearoff and remain attached to the adhesive composition 1303 upon removal ofthe barrier device 1301. A portion of the adhesive composition 1303 mayremain on the skin 1 and slough off over time as the outer layer of skin1 desquamates (i.e., the outer layer of dead skin flakes or peels off).

FIG. 13B illustrates the embodiment of a barrier device 1301 on the skin1 of a patient surrounding an aperture 2. In the illustrated embodiment,the adhesive composition 1303 adheres the barrier device 1301 to theskin 1, enclosing the aperture 2 underneath the barrier device 1301. Thebarrier device 1301 may reduce incidences of infection at or in anaperture 2 (e.g. a wound or incision). In one embodiment, once thebarrier device 1301 has been adhered to the skin 1 of a patient,bacteria 3, viruses, prions, or toxic chemicals cannot penetrate thebarrier device 1301 and gain access to the aperture 2. In anotherembodiment, the barrier device 1301 may be gas impermeable. In yetanother embodiment, the barrier device 1301 may be liquid impermeable.In yet another embodiment, the barrier device 1301 blocks access to theaperture 2 for any unwanted matter.

FIG. 13C is a zoomed in illustration of an embodiment where a bladder1302 has been inflated. In the illustrated embodiment, the bladder 1302is configured to remain attached to the bottom surface 1305 of thebarrier device 1301 upon inflation. The bladder 1302 may also bedisposed at the perimeter edge 1306 of the device, as shown in FIG. 14.The bladder 1302 may be made of any medically acceptable materialcapable of expansion, and which is impermeable to a fluid used toinflate it. For example, the bladder may be made of plastics, rubbers,nitrile, polyurethanes, polyethylenes, ethylene propylene diene monomer(EPDM), vinyl, silicone elastomers, neoprene, or combinations thereof.

In the illustrated embodiments of FIGS. 13C and 14, a fluid may beinjected into the inner chamber 1307, 1407 of the bladder 1302, 1402 toinflate the bladder 1302, 1402 either through the bladder wall 1309,1409 or via the barrier device 1301, 1401. For example, a hypodermicneedle may puncture the bladder wall 1309, 1409 and inject a fluiddirectly into the inner chamber 1307, 1407, the puncture hole acting asa port. Alternatively, the inner chamber 1307, 1407 of the bladder 1302,1402 may be in fluid communication with an inner chamber (not shown) ofthe barrier device 1301, 1401. An inner chamber of a barrier device1301, 1401 may be similar to the inner chamber 1507 of an embodimentillustrated on FIGS. 15A and 15B. In this way, a fluid may be injectedthrough a port 1510, located on a top layer 1504 of the barrier device1501, as shown in FIGS. 15A and 15B, and into the inner chamber 1307,1407 of the bladder 1302, 1402 shown in FIGS. 13A-14. In yet anotherexample, a port, such as the port 1510 illustrated in FIGS. 15A and 15B,may be attached directly to the bladder 1302, 1402. The ports describedherein may include a one-way valve, such that, for example, fluid may beintroduced into the port without being able to exit the port. Forinstance, a one-way valve may be placed just below the port. In at leastone embodiment, this would allow the use of a smaller syringe to fill abladder with a volume larger than that of the syringe or otherfluid-delivery device.

Certain portions of the bladder 1302 may expand more or less than othersdepending on the thickness of the bladder wall 1309. For example, abottom portion of the bladder wall 1309 in contact with the adhesivecomposition 1303 at the bladder-adhesive interface 1308 may be thinnerthan the rest of the bladder wall 1309. This may result in the portionof the bladder 1302 at the bladder-adhesive interface 1308 expandingmore than the rest of the bladder 1302. These portions of the bladder1302, which are in contact with the adhesive composition 1303, may bemore prone to expand upon inflation. This may more efficiently weaken abond between the bladder and the bladder 1032 and adhesive composition1303.

Providing embodiments of the barrier device 1301, wherein the bladderwall 1309 has thin portions, is merely one method to enable certainareas of the bladder 1302 to expand more than others. Embodimentsincluding bladders 1302 that have a constant wall thickness may stillexpand upon inflation and weaken a bond between the bladder and theadhesive. Expansion of the bladder 1302 may be done using a hypodermicneedle to puncture the bladder 1302 and introduce a fluid into the innerchamber 1307. A port 1510, such as a Luer lock connection, may also beused to introduce a fluid 1511 into the inner chamber 1307, 1507, asshown in FIGS. 15A-16A and described in detail below. Any otherconnection through which a fluid 1511 may be introduced into an innerchamber 1307, 1507 of the barrier device may be used. Once a bondbetween the bladder 1302 and the adhesive composition 1303 is weakened,the barrier device 1301 may be more easily removed.

In other embodiments, such as those illustrated in FIGS. 15A-B, an innerchamber 1507 may be enclosed between, and/or at least partially definedby, top and bottom layers 1504, 1505 of the barrier device 1501. The toplayer 1504 may be made of materials of other embodiments of barrierdevices described herein. The bottom layer 1505 of the barrier device1501 may have compliant portions 1512. The compliant portions 1512 andbottom layer 1505 may be made of any medically acceptable elastic orplastic material capable of expansion, and which is impermeable to afluid used to inflate it. For example, the compliant portions 1512 andbottom layer 1505 may be made of plastics, rubbers, nitrile,polyurethanes, polyethylenes, ethylene propylene diene monomer (EPDM),vinyl, silicone elastomers, neoprene, or combinations thereof.

In the embodiment of the barrier device 1501 illustrated in FIGS. 15A-B,a single inner chamber 1507 is partially defined by the entire bottomlayer 1505. In another embodiment, the barrier device 1501 may havemultiple inner chambers 1507, which may each be partially defined by oneor more distinct portions of the bottom layer 1505. In otherembodiments, each inner chamber 1507 may be accessed independently by aport 1510. In other embodiments, a port 1510 may be a means forintroducing a fluid into multiple inner chambers 1507 simultaneously.

It will be noted that other embodiments of the barrier device 1501 mayinclude one or more components and/or features of other embodimentsdescribed herein. For example, one embodiment of a barrier device mayinclude a combination of a bottom layer 1505 with compliant portions1512 as well as one or more bladders 1302 disposed on a bottom surfaceof the bottom layer 1505. Other embodiments may include combinations ofembodiments herein described where the number and configuration ofports, bladders 1302, compliant portions 1512, and top 1504 and bottomlayers 1505 may vary.

The adhesive composition 1503 may be applied so that only the compliantportions 1512 of the bottom layer 1505 binds to the skin 1. In oneembodiment, an adhesive composition 1503 may be first applied to thecompliant portions 1512 and subsequently adhered to the skin 1. Inanother embodiment of the barrier device 1501, the adhesive composition1503 may first be applied directly to the skin 1 of a patient. Forexample, the adhesive composition 1503 may first be applied to the skin1 of a patient around an aperture. The barrier device 1501 may then beplaced onto the skin 1 so that the compliant portions 1512 make contactwith the adhesive composition 1503 on the skin 1. In yet anotherembodiment, the bottom layer 1505 may be separate from the top layer1504. In this embodiment, the compliant portions 1512 of the bottomlayer may first be adhered to the skin 1, and the top layer 1504 maysubsequently be adhered to the bottom layer 1505. The adhesivecomposition 1503 may include one or more adhesive compositions describedherein.

FIGS. 15A and 15B generally illustrate a barrier device having a toplayer 1504 and a bottom layer 1505 joined at the perimeter edge of thebarrier device 1501 to form an inner chamber 1507. In this embodiment,the port 1510 is a Luer lock connection, through which the inner chamber1507 may be accessed. The port 1510 may be comprised of otherconnections that serve as means to introduce a fluid 1511 into the innerchamber 1507. A port may also include a puncture hole. For example, ahypodermic needle may puncture the barrier device 1501 or bladder 1302,wherein a fluid is introduced into the inner chamber 1507 through theneedle.

The bottom layer 1505 of the barrier device 1501 shown in FIGS. 15A and15B includes thick walled portions 1513 and thin walled portions 1512.The thickness of the thin walled portions 1512 may be from 0.01 mm to 2mm. The thickness of the thick walled portions 1513 may be from 1 mm to5 mm. An adhesive composition 1503 may be applied only to the thinwalled portions 1512 of the bottom layer 1505. In this way, asillustrated in FIG. 15B, the thin walled portions 1512 may expand when afluid 1511 is introduced into the inner chamber 1507 through a port 1510before the thick walled portions 1313. The barrier device 1501 can bemore easily removed upon expansion similar to the way that the expansionof the bladder 1302 shown in FIG. 13C facilitates removal of the barrierdevice 1301, as described above. The top layer 1504 of the embodimentillustrated in FIGS. 15A and 15B may be more rigid than the bottom layer1505, or at least more rigid than the thin walled portions 1512 of thebottom layer 1505, so as to be more resistant to expansion upon theintroduction of a fluid 1511 into the inner chamber 1507. In someembodiments, both the thin walled portions 1512 and the thick walledportions 1513 may expand.

Referring generally to FIGS. 16A-B, FIG. 16A illustrates a top view ofan embodiment of a barrier device 1601. In the illustrated embodiment,the barrier device 1601 is generally rectangular in shape. Otherembodiments may be other shapes so as to cover a variety of apertures.For example, the barrier device 1601 may be circular, elliptical,polygonal, rectangular, otherwise shaped or a combinations thereof.

The barrier device 1601 may include a port 1610. The port 1610 may beaccessed from a top layer 1604 of the barrier device. In the embodimentshown in FIG. 16A, the port 1610 is a Luer lock connection. In otherembodiments, the port 1610 may be located directly on a bladder (notshown) or compliant portions 1612. In other embodiments, the port 1610may be located on, or accessed from, different locations on the topand/or side of the barrier device 1601 other than the location of theport 1610 illustrated. Other embodiments, herein describing the locationof one or more ports 1610 and/or compliant portions 1612 and/or bladders(not shown), may also be included.

FIGS. 16B and 17 illustrate a bottom view of the bottom surface 1605,1705 of various embodiments of a barrier device 1601, 1701. In theembodiment illustrated in FIG. 16B, an expandable portion 1612 may bedisposed relative to the perimeter of the barrier device 1601. Thisexpandable portion 1612 may be an inflatable bladder 1302, similar tothe embodiments shown in FIGS. 13A-14. The expandable portion 1612 mayalso be a thin walled portion 1512 of the lower layer 1505 of thebarrier device similar to the embodiment illustrated in FIGS. 15A and15B and described herein.

As shown in FIG. 16B, the barrier device 1601 may include an absorptivematerial 1614. The absorptive material 1614 may be disposed within theperimeter of the expandable portion 1612. The absorptive material 1614may be positioned so it overlies an aperture (e.g., a wound or surgicalcut). The absorptive material 1614 is configured to absorb fluids thatooze from an aperture. Hydrogels and similar compounds may be utilizedto absorb fluids. The absorptive material 1614 may containantimicrobials or other wound healing co-factors. Antimicrobialcompounds designed for elution may include, but are not limited to,chlorhexidine, silver ions, copper ions, rifampin, and minocycline.

FIG. 17 illustrates an embodiment of the barrier device similar to FIG.16B, but where a pressure sensitive adhesive (PSA) 1715 is disposed onthe bottom-most surface 1705 of the barrier device 1701. The PSA 1715may assist in securing the barrier device 1701 onto the skin of apatient. In some embodiments, the use of PSA 1715 may facilitate the useof less adhesive composition (e.g., adhesive composition 1303) thusfacilitating easier removal of the barrier device 1701 than embodimentswhere more adhesive composition is used. As shown in FIG. 17, the PSA1715 may be disposed along the inside and outside perimeter of theexpandable portion 1712 of the bottom surface 1705 of the device 1701.The PSA may be distributed anywhere on the bottom surface 1705 of thebarrier device 1701. For example, the PSA 1715 may be disposed onlywithin the expandable portion 1712 or only outside a perimeter of theexpandable portion 1712. The PSA 1715 may also, for example, be disposedat the four corners of the bottom surface 1705 of the barrier device1701. The configuration of the PSA 1715 on the bottom surface 1705 ofthe barrier device 1701 may depend on the shape and configuration of thebarrier device 1701. One may appreciate, in light of the currentspecification, that the PSA 1715 may be disposed on any portion of thebarrier device 1701. In some embodiments, the PSA 1715 may be disposedon a portion of the expandable portion 1712, but at least a portion ofthe expandable portion 1712 must include adhesive composition.

Adhesive composition may be applied to the expandable portions 1612,1712 on the bottom surfaces 1605, 1705 of the barrier devices 1501,1601, 1701 illustrated in FIGS. 15A-17 in order to adhere the barrierdevice 1501, 1601, 1701 to the skin 1 of a patient. The expandableportions 1512, 1612, 1712 may completely enclose an aperture beneath thebarrier device 1501, 1601, 1701 within a closed perimeter of theexpandable portion 1512, 1612, 1712. The adhesive composition 1503 mayinclude one or more adhesive compositions described herein.

In some embodiments, an adhesive composition may be pre-applied to abarrier device and enclosed until use. As shown in FIGS. 18A and 18Billustrate, an embodiment of a barrier device 1801 may include anadhesive composition 1803 that resides in a groove 1816 in the bottomsurface 1805 of the barrier device 1801. A seal 1817 may span theadhesive composition 1803 and/or the groove 1816 and may seal theadhesive composition 1803 (e.g., within the groove 1816). The adhesivecomposition 1803 and the seal 1817 may be placed on or in the barrierdevice 1801 during the manufacturing of the barrier device 1801. Theseal 1817 may prevent the adhesive composition 1803 from exposure toair, thus preventing polymerization, until the seal is removed and/orthe barrier device 1801 is adhered to a surface. The adhesivecomposition 1803 may be released to make contact with the skin 1 of apatient and adhere the barrier device 1801 to the skin 1 upon a removalof the seal 1817.

FIG. 18B illustrates an embodiment of an easy-release seal 1817. A seal1817 may include a pull tab 1818 to make a removal of the seal easier.For example, a person removing the seal 1817 may grab the pull tab 1818and remove the seal 1817 by pulling it away from the barrier device1801. Once the seal 1817 is removed and the adhesive composition 1803 isexposed to air, the adhesive composition 1803 may have a window of timebefore it polymerizes. The barrier device 1801 may be positioned on theskin of a patient within this window of time. That is, after the removalof the seal 1817 but prior to polymerization of the adhesive composition1803. It will be appreciated in light of the current disclosure that theembodiment shown in FIGS. 18A and 18B, including an adhesive composition1803 residing in a groove 1816 and covered by a removable seal 1817, maybe utilized in any other embodiment described herein. For example, theembodiments illustrated in FIGS. 13A-17 may all be comprised of anadhesive composition 1803 covered by a removable seal 1817. In someembodiments, a groove 1816 may be disposed on the bottom surface 1805 ofthe barrier device 1801 to correspond with the location of the compliantportions 1712 or bladders 1302 of other embodiments herein described.

FIG. 19 illustrates an embodiment of a barrier device 1901 where theadhesive composition 1903 resides in a plurality of capsules on thebottom surface 1905 of the barrier device 1901. In the illustratedembodiment, the adhesive composition 1903 may, for example, be containedin microcapsules. The microencapsulated adhesive composition 1903remains unexposed to air until the outer surface of the microcapsules isbreached. A person applying the barrier device 1901 on the skin 1 of apatient may position the barrier device 1901 as desired then press downon the top surface 1904 of the barrier device above where theencapsulated adhesive composition 1903 is disposed underneath. Pressureapplied to the capsules may cause a plurality of the capsules to open,thus releasing the adhesive composition 1903 and adhering the barrierdevice 1901 to a surface.

The capsules may be many different sizes and made of many differentmaterials. Capsules may be made of starch, dextrins, sucrose, cellulose,chitosan, gums (arabic gum, alginate and carrageenan), lipids (wax,paraffin, monoglycerides and diglycerides, hydrogenated oils and fats),calcium sulfate, silicates and proteins (gluten, casein, gelatin andalbumin), polyvinyl alcohol, or combinations thereof.

It will be appreciated in light of the current disclosure that theembodiment shown in FIG. 19, including an encapsulated adhesivecomposition 1903 may be utilized in any other embodiment describedherein. For example, the embodiment illustrated in FIGS. 13A-17 may allbe comprised of an encapsulated adhesive composition that releases theadhesive composition 1903 when a force or pressure is applied to thecapsules. Furthermore, a combination of embodiments shown in FIGS.18A-18B and FIG. 19 may also be provided. For example, the adhesivecomposition 1803 residing in the groove 1816 shown in the embodiment ofthe barrier device 1801 illustrated in FIGS. 18A-18B may be anencapsulated adhesive composition 1903 as illustrated in the embodimentof FIG. 19. Alternatively, the adhesive composition 1303 illustrated inFIGS. 13A-15B may comprise an encapsulated adhesive compound and/orreside in grooves 1816 and/or sealed by a seal 1817.

III. Wound Closure Tensioning Anchor

An embodiment of a wound closure tensioning anchor 2001 is illustratedin FIG. 20A. The tensioning anchor 2001 includes a base member 2020, areceiving member 2022, and an expandable membrane 2012. In someembodiments the tensioning anchor 2001 may include a port 2010. Asshown, the tensioning anchor 2001 may be used with a connecting member2021. The base member 2020 and receiving member 2022 may be comprisedany medically acceptable material. That is, any material that is usedfor a medical device may be used in preparing an anchor 2001 asdescribed and shown herein. For example, the base member 2020 and/orreceiving member 2022, may be prepared from rubbers, elastomers,bandage-like materials, cloths, fibrous materials, paper, porousmaterials, plastics, hard plastics, malleable plastics, polyethylenes,polystyrenes, foams, polyurethanes, latexes, and the like.

The base member 2020 illustrated in FIG. 20A is elliptical in shape. Inother embodiments of the anchor 2001, the base member 2002 may berectangular, polygonal, circular, otherwise shaped, or any combinationof such shapes. Other embodiments of the base member 2020 may beirregularly shaped.

In FIG. 20A, the receiving member 2022 is shown as a cylindrical postextruded from the top of a base member 2020. In the illustratedembodiment, the connecting member 2021 may be secured to the receivingmember 2022. The receiving member 2022 shown is one example of areceiving member, but the receiving member 2022 may be otherwise shaped.In at least one embodiment, the receiving member may be configured toreceive a connecting member 2021 and limit movement of the connectingmember 2021 relative to the connecting member 2021. In at least oneembodiment, the receiving member 2022 may withstand a force exerted bythe connecting member 2021 without failing. In some embodiments, thereceiving member 2022 may be a pin or a hook. Alternatively, thereceiving member 2022 may be formed in the base member 2020 such thatthe connecting member 2021 may be inserted and/or retained by the basemember 2020.

The receiving member 2022 may be rigidly connected to a base member 2020so as to transfer a force applied by a connecting member 2021 to thebase member 2020 or anchor 2001 in general. As shown, the receivingmember 2022 may include a retaining feature (not labeled) that may limitmovement of a connecting member 2021 in at least one direction. Forexample, as shown, the retaining feature may limit vertical movement(e.g., away from a top surface of the anchor 2001) of the connectingmember 2021.

In some embodiments, it may be desirable for receiving member 2022 toreceive the connecting member 2021 as close to a bottom surface of theanchor 2001 as possible. Receiving a connecting member 2021 close to thebottom surface may minimize the moment of a force exerted by theconnecting member 2021 on the receiving member 2022. For example, thefurther the distance from the bottom surface that the connecting member2021 is connected, the larger the moment applied to the anchor 2001.Receiving the connecting member 2021 near the bottom surface mayminimize these perpendicular forces (e.g., moments) and/or may transferthe force from the connecting member 2021 into a shear force spread outover the bottom surface of the anchor 2001. In one or more embodiments,the receiving member 2022 may receive the connecting member 2021 withina thickness of the base member 2020 or below the base member 2020.

For example, a ratio of a major dimension 2028 of the base member 2020of the anchor 2001 to a distance above the skin where the connectingmember 2021 is received may be less than three. In other words, themajor dimension 2028 may be at least three times greater than a distanceabove the skin where the receiving member 2022 receives the connectingmember 2021. In embodiments where the ratio of major dimension 2028 toheight of the connecting member 2021 is less than 3, the base member2020 may be large enough and/or stable enough to minimize theperpendicular forces applied to the skin by a lever arm of the receivingmember 2022.

The receiving member 2022 is shown as not being centrally located in thebase member 2020. The receiving member 2022 may be located closer to afront edge relative to the major dimension 2028. For example, thereceiving member 2022 may be spaced one third of the major dimension2028 from the front edge. Spacing the receiving member 2022 closer tothe front edge may increase the ability of the base member 2020 toresist forces applied by the connecting member 2021.

As illustrated in FIG. 20A, the connecting member 2021 may be a wire.The wire may be made of any material suitable to sustain a desired forceon the anchor 2001 without breaking, stretching, elongating, orotherwise failing. Such materials may include plastic, metal, fabric,yarn, thread, or the like. Although a more elastic material may be used,forces applied by the anchor 2001 may be more directly applied to theskin in embodiments with a connecting member 2021 that is more rigidthan elastic.

FIGS. 20A and 20B illustrate an embodiment of an anchor 2001 where theexpandable membrane 2012 is an inflatable bladder disposed around aperimeter edge of the base member 2020. The anchor 2001 may be adheredto the skin of a patient while the expandable membrane 2012 is deflated.An adhesive composition may be applied to a bottom surface of theexpandable membrane 2012 configured to make contact with the skin. Afluid may enter an inner chamber (not shown) through the port 2010 inorder to expand the expandable membrane 2012. When the expandablemembrane 2012 expands, the surface area of the expandable membrane 2012increases and a bond between the expandable membrane 2012 and theadhesive composition is weakened. The anchor 2001 can then be removed,in at least one embodiment, without tearing and/or injuring the skin. Amore detailed description of the weakening of the bond between theexpandable membrane 2012 and the adhesive composition is given belowwhen referring to FIGS. 22A-B.

In FIGS. 20A and 20B, a port 2010 is located on the base member 2020.Fluid received into the port 2010 may travel to an inner chamber (notshown) of the expandable membrane 2012 through an inner chamber (notshown) within the base member 2020. In some embodiments, the port 2010may be provided directly on the expandable membrane 2012 and/or it maybe a puncture hole from a needle.

FIG. 20C illustrates an embodiment of an anchor 2001, similar to theanchor 2001 illustrated in FIG. 20A, but without a predefined port. Forexample, a hypodermic needle may directly pierce the expandable membrane2012 to inject a fluid. Introducing a fluid into an inner chamberenclosed in the expandable membrane 2012 causes the expandable membrane2012 to expand. The surface area of the expandable membrane 2012increases upon expansion, weakening the bond between the adhesivecomposition and the expandable membrane 2012. The weakening of the bondbetween the adhesive composition and the expandable membrane 2012 isdescribed in more detail below when referring to FIGS. 22A-B. Once thisbond has been weakened, pulling the anchor 2001 away from the skin willremove it from the patient. Portions of the adhesive composition mayremain on the skin and eventually slough off over time as the outerlayer of skin desquamates.

A wall thickness of the expandable membrane 2012 illustrated in FIGS.20A-20C (and in other embodiments described herein) may or may not be aconstant. The expandable membrane 2012 may expand more where the wall isthinner. It may be advantageous to have thin walled portions of theexpandable membrane 2012 where expansion is desired most. For example,the portion of the expandable membrane 2012 that makes contact with theskin, and where the adhesive composition is applied, may have a thinnerwall thickness than the rest of the bladder. This may result in thegreatest expansion occurring at areas of the expandable membrane 2012where separation from the adhesive composition is most desired. That it,at an interface between the expandable membrane 2012 and the adhesivecomposition.

FIGS. 20A and 20B illustrate an embodiment of an anchor 2001 with a port2010. The port 2010 is configured to receive a fluid into an innerchamber (not shown). In the illustrated embodiment, the port 2010 isconfigured to receive a fluid through the receiving member 2022. Theexpandable membrane 2012 is a bladder disposed at the perimeter edge ofthe anchor 2001. The port 2010 may also be separate from the receivingmember 2022 and located elsewhere on the base member 2020. For example,in some embodiments, the port 2010 may be separate from the receivingmember 2022, as illustrated in FIG. 24 and described in more detailbelow. The port 2010 may also be located directly on the expandablemembrane 2012 itself. For example, the port 2010 may also be ahypodermic needle puncture hole in the expandable membrane 2012. In theembodiment illustrated in FIG. 20A, the port 2010 is a Luer lockconnection, enabling a syringe with a complimentary Luer connection tobe attached. Other connections may be utilized that enable injection ofa fluid through the port 2010. For example, the port 2010 may be a Luerconnection located on the expandable membrane 2012. Also, for example,an inner chamber (not shown) of the expandable membrane may be in fluidcommunication with an inner chamber (not shown) of the base member 2020.In this way, fluid may be injected through the port 2010, located on thebase member 2020, as illustrated in FIG. 20A, and into an inner chamberof the expandable membrane.

A side view of an embodiment of a tensioning anchor 2101 is shown inFIG. 21. In the illustrated embodiment, a port 2110 is configured toreceive a fluid through the receiving member 2122 located on the topsurface 2104 of the base member 2120. A syringe or other inflationdevice may be connected to the port 2110 via, for example, a Luer lockconnection.

The receiving member 2122 may include a pulley mechanism 2123 aroundwhich a connecting member 2121 may be wrapped and routed to anotheranchor 2101. For example, as shown FIG. 27, a single connecting member2721 may be used to connect three or more anchors. In other words, ananchor may use a pulley mechanism 2123 to receive a connecting memberthat may be retained vertically and positionally, but which may stillmove along its length. In some embodiments, a pulley mechanism 2123 mayreduce friction between the receiving member 2122 and the connectingmember 2121.

An adhesive composition may be applied to the bottom surface 2105 of theanchor 2101 and the anchor 2101 may be adhered to the skin of a patient.The adhesive composition may be similar to the adhesive compositionsdescribed herein.

FIG. 22A is a zoomed in illustration of an embodiment of an anchor 2201where the expandable membrane is a bladder 2202 disposed on the bottomsurface 2205 of the anchor 2201 near or at the perimeter edge 2206 ofthe anchor 2201. The bladder 2202 may also be disposed at the perimeteredge 2206 of the device, similar to the configuration of a bladder on abarrier device illustrated in FIG. 14. The bladder 2202 is deflated inFIG. 22A and inflated in FIG. 22B. In the illustrated embodiment, thebladder 2202 is configured to remain attached to the bottom surface 2205of the anchor 2201 upon inflation. In the illustrated embodiments ofFIGS. 22A and 22B, fluid may be injected into the inner chamber 2207 ofthe bladder 2202 to inflate the bladder 2202 either through the bladderwall 2209 or via the anchor 2201. For example, a hypodermic needle maypuncture the bladder wall 2209 and inject a fluid directly into theinner chamber 2207, the puncture hole acting as a port. Also, forexample, the inner chamber 2207 of the bladder 2202 may be in fluidcommunication with an inner chamber (not shown) of the anchor 2201. Inthis way, a fluid may be injected through a port into the inner chamber2207 of the bladder 2202. In yet another example, a port, such as theport 2010 illustrated in FIG. 20, may be attached directly to thebladder 2202.

In one embodiment, the bladder 2202 may be disposed at the perimeteredge 2206, as shown in FIGS. 22A-B. In one embodiment, the distance ofthe bladder 2202 from the perimeter edge 2206 on the bottom surface 2205of the anchor 2201 may vary. Also, multiple bladders 2202 may bedisposed on the anchor 2201. For example, a first bladder 2202 may bedisposed at the perimeter edge 2206 of the anchor 2201 and a secondbladder 2202 may be disposed on the bottom surface 2205 adjacent to theperimeter edge 2206. Also, for example, a first bladder 2202 may bedisposed on the bottom surface 2205 adjacent to the perimeter edge 2206and a second bladder 2202 may be disposed on the bottom surface 2205further away from the perimeter edge 2206. In one embodiment, thecross-sectional dimensions of the bladder 2202 may vary. Otherembodiments of an anchor 2201 and bladder 2202 configurations mayinclude any combination of other embodiments herein described. Thebladder 2202 may be manufactured separately from the anchor 2201 andsubsequently fixed to the anchor 2201. Alternatively, the bladder 2202may be manufactured and/or molded in conjunction with the anchor 2201 asa single piece.

Different portions of the bladder 2202 may expand more or less thanothers depending on the thickness of the bladder wall 2209. For example,a bottom portion of the bladder wall 2209 in contact with the adhesivecomposition 2203 at the bladder-adhesive interface 2208 may be thinnerthan the rest of the bladder wall 2209. This may cause the portion ofthe bladder 2202 at the bladder-adhesive interface 2208 to expand morethan the rest of the bladder 2202. These portions of the bladder 2202,which are in contact with the adhesive composition 2203, may be moreprone to expand upon inflation. This may more efficiently weaken a bondbetween the bladder and the adhesive.

The preceding examples of the anchor 2201, where the bladder wall 2209has thin portions, is merely one method to enable certain areas of thebladder 2202 to expand more than others. Embodiments including bladders2202 that have a constant wall thickness will still expand uponinflation and weaken a bond between the bladder 2202 and the adhesivecomposition 2203. Expansion of the bladder 2202 may be done using ahypodermic needle to puncture the bladder 2202 and introduce a fluidinto the inner chamber 2207. A port 2110, such as a Luer lock connectionillustrated in FIG. 21, may also be used to introduce a fluid into theinner chamber 2207. Any other connection through which a fluid may beintroduced into the inner chamber 2207 of the bladder 2202 may be used.Once a bond between the bladder 2202 and the adhesive composition 2203is weakened, the anchor 2201 may be more easily removed.

In the embodiment illustrated in FIG. 22A, an adhesive composition 2203has been applied to only a bladder 2202 so that only the bladder 2202adheres to the skin. This allows for removal of the anchor 2201 uponinflation of the bladder 2202. Inflation of the bladder 2202 increasesthe surface area of the bladder 2202, which puts a stress on thebladder-adhesive interface 2208, thus weakening a bond between thebladder 2202 and the adhesive composition 2203. The illustratedembodiment shows a bladder 2202 that is deflated, which may beappropriate during the application and/or use of the anchor 2201. A portis not shown in FIGS. 22A and 22B, but may include, for example, apuncture hole from a hypodermic needle or other fluid injector.

Inflation of the bladder 2202 increases the surface area of the bladder2202. This expansion creates a stress at an interface 2208 between thebladder 2202 and the adhesive composition 2203 because the adhesivecomposition 2203 may not expand as much as the bladder 2202. Theexpansion of the bladder 2202 weakens a bond between the bladder 2202and the adhesive composition 2203.

FIGS. 22A and 22B are illustrative of how inflating the bladder 2202 mayweaken the bond between the bladder 2202 and the adhesive composition2203. FIG. 22A illustrates an embodiment of a bladder 2202 similar tothe bladder 1302 illustrated in FIG. 13B, but where the bladder 2202 hasbeen deflated. The interface 2208 between the bladder 2202 and theadhesive composition 2203 is greater than the interface 2208 between aninflated bladder 2202 and the adhesive composition 2203, such as theinterface 2208 shown in FIG. 22B. That is, the surface area of thebladder 2202 that is in contact with the adhesive composition 2203 isgreater in FIG. 22A than it is in FIG. 22B. Also, the circumference ofthe bladder 2202 is greater when inflated, as illustrated in FIG. 22B.Therefore, an inflated bladder 2202 puts a stress at thebladder-adhesive interface 2208 by increasing the circumference of thebladder 2202, while the adhesive composition 1303 may be more resistantto expansion. This stress at the bladder-adhesive interface 2208 resultsin portions of the bladder 2202 breaking free from portions of theadhesive composition 2203. As a result, the surface area of the bladder1302, which is bonded to the adhesive composition 2203, is reduced wheninflated.

In one embodiment, the inflated bladder 2202 may completely detach fromthe adhesive composition 2203. In another embodiment, the inflatedbladder 2202 may only partially detach from the adhesive composition2203. In one embodiment, once the bond between the bladder 2202 and theadhesive composition 2203 has been weakened, the anchor 2201 may be moreeasily removed, while reducing the incidences of injury to the skin. Inone embodiment, portions of the bladder 2202 may tear off and remainattached to the adhesive composition 2203 upon removal of the anchor2201. A portion of the adhesive composition 2203 may remain on the skinand slough off over time as the outer layer of skin desquamates (i.e.,the outer layer of dead skin flakes or peels off).

FIGS. 23A and 23B illustrate an embodiment of an anchor where theexpandable membrane is a bottom layer 2312 of a base member 2320. Theillustrated embodiment of the anchor 2301 may include a base member 2320having a bottom layer 2312 enclosing an inner chamber (not shown). Thebottom layer 2312 may be compliant and expandable. As illustrated inFIGS. 23A and 23B, the introduction of a fluid into the internal chamber(not shown) by a syringe 2329 via the port 2310 causes the expandablebottom layer 2312 to expand. This expansion increases the surface areaof the bottom layer 2312, which stresses a bond between the adhesivecomposition and the bottom layer 2312. This stress weakens the bond andallows the anchor 2301 to be removed from the adhesive composition andtherefore the patient.

The bottom layer 2312 of the anchor 2301 illustrated in FIGS. 23A and23B may have thick walled portions and thin walled portions. An adhesivecomposition may be applied only to the thin walled portions of thebottom expandable layer 2312. In this way, the thin walled portionsexpand more than the thick walled portions when a fluid is introducedinto the inner chamber (not shown) through the port 2310. The basemember 2320 may be more rigid than the bottom layer 2312, or at leastmore rigid than the thin walled portions of the bottom layer 2312, so asto be more resistant to expansion upon the introduction of a fluid intothe inner chamber (not shown). The thin walled portions of the bottomlayer 2312 may be made of any medically acceptable elastic or plasticmaterial capable of expansion, and which is impermeable to a fluid usedto inflate it. For example, the bladder may be made of plastics,rubbers, nitrile, polyurethanes, polyethylenes, ethylene propylene dienemonomer (EPDM), vinyl, silicone elastomers, neoprene, or combinationsthereof.

In the embodiment of the anchor 2301 illustrated in FIGS. 23A-B, asingle inner chamber (not shown) is partially defined by the entirebottom layer 2312. In another embodiment, the anchor 2301 may havemultiple inner chambers, which may each be partially defined by one ormore distinct portions of the bottom layer 2312. In other embodiments,each inner chamber may be accessed independently by a port 2310. Inother embodiments, a port 2310 may be a means for introducing a fluidinto multiple inner chambers simultaneously.

Other embodiments of the anchor 2301 may include combinations ofcomponents or features of other embodiments herein described. Forexample, one embodiment of an anchor may include a combination of abottom layer 2312 with compliant portions as well as one or morebladders 2202 disposed on a bottom surface of the bottom layer 2212.Other embodiments may include combinations of embodiments hereindescribed where the number and configuration of ports, bladders 2202,compliant portions 2212, base members 2020, and bottom layers 2005 mayvary.

Referring back to FIG. 22A-B, the adhesive composition 2203 may beapplied so that only the bladder 2202 (or expandable bottom layer 2312illustrated in FIGS. 23A-B) binds to the skin. In one embodiment, anadhesive composition 2203 may be first applied to the bladder 2202 andsubsequently adhered to the skin. In another embodiment of the anchor2201, the adhesive composition 2203 may first be applied directly to theskin of a patient. For example, the adhesive composition 2203 may firstbe applied to the skin of a patient around an aperture. The anchor 2201may then be placed onto the skin so that the one or more bladders 2202make contact with the adhesive composition 2203 on the skin. In yetanother embodiment, the bottom layer 2212 of the anchor illustrated inFIG. 23A-B may be separate from the base member 2320. In thisembodiment, the expandable bottom layer 2312 may first be adhered to theskin, and the base member 2320 may subsequently be adhered to the bottomlayer 2312. The adhesive composition 2203 may include one or moreadhesive compositions described herein.

At least a portion of one or more of the bottom surfaces (e.g., bottomsurface 1305,1505, 1605, 1705, 1805, 1905, 2005, 2105, 2205) describedherein may include surface characteristics. For example, the surfacecharacteristics may include ridges, dimpling, scales, surfaceroughening, other surface characteristics, or combinations thereof. Insome embodiments, the surface characteristics may be directionallyoriented. For example, one or more of the surface characteristics (e.g.,angled ridges and/or wave-like ridges may be at an acute angle) may haveincreased friction in at least one direction (e.g., similar to sharkscales). The direction of the surface characteristics may be indicatedon the surface of the device to allow the device to be placed such thatthe surface characteristics may be aligned with in a predeterminedorientation.

In the embodiment illustrated in FIG. 24, an adjustment mechanism 2424may be coupled to the receiving member 2422. The port 2410 may beseparate from the adjustment mechanism 2424 and/or receiving member2422, but they may also be integrated together. In the illustratedembodiment, the adjustment mechanism 2424 is a dial. The dial 2424 maybe rotated in one direction to draw in the connecting member 2421 intowards the anchor 2401 or rotated in the other direction to release theconnecting member 2421 out away from the anchor 2401. Other adjustmentmechanisms 2424 may be used that release out and or draw in theconnecting member 2421 upon activation.

The dial 2424 shown in an embodiment of the anchor 2401 illustrated inFIG. 24 may include a ratchet mechanism, wherein a rotation of the dial2424 in only one direction is possible. In this way, a connecting member2421 may be drawn in toward the anchor 2401 and locked in place. Thismay prevent the connecting member 2421 from being released out away fromthe anchor 2401 unintentionally due to a tension in the connectingmember 2421. Other locking mechanisms may be employed that prevent theconnecting member 2421 from being drawn out away from the anchor 2401.For example, a clamp or a set screw may be used to lock the connectingmember 2421 in place. A release mechanism may also be provided in orderto unlock the adjustment mechanism 2424 and allow the connecting member2421 to be released out away from the anchor 2401, thus decreasing atension in the connecting member 2421.

In another embodiment, a tensioning anchor 2421 may include ventilationfeatures 2427. The ventilation features may be configured to promoteairflow to the skin of a patient when an anchor has been adhered to theskin. For example, in an embodiment shown in FIG. 24, where expandablemembrane 2412 is disposed at a perimeter edge of the anchor 2401, slits,holes, or cuts may be present in the base member 2420 to allow air toflow through the anchor 2401. Other ventilation features that allow airto flow through the anchor 2401 to access the skin may also be utilized.These may include holes, screens, vents, mesh material, fabric sections,or other breathable materials sections of the base member 2420.

In the embodiment illustrated in FIG. 25, an anchor 2501 includes aspring 2526 coupled to an adjustment mechanism 2524. The spring 2526 maybias the adjustment mechanism 2524 in either direction. For example, thespring 2526 may exert a force on the adjustment mechanism 2524 inopposition to a tension force exerted by the connecting member 2521.This configuration may encourage a release of the connecting member 2521when the adjustment mechanism 2524 is unlocked. Alternatively, thespring 2526 may also be configured to exert a force on the adjustmentmechanism 2524 in the other direction, thus discouraging a release ofthe connecting member 2521 when the adjustment mechanism 2524 isunlocked.

Another embodiment of a tensioning anchor may include a force gauge (notshown). A force gauge may measure the force exerted by the anchor 2501on the skin of a patient and relay the information to the user. Theforce gauge may be located anywhere on the anchor 2501 so as toeffectively measure and communicate the exerted force. The force gaugemay be digital or analog. The force gauge may provide visual or audiofeedback to a person installing the anchor on a patient, alerting themof the force exerted by the anchor 2501 on the skin of a patient.

FIG. 25 illustrates an embodiment of an anchor 2501 that may include anadjustment mechanism 2524 with a torque limiting slip clutch 2525. Sucha slip clutch 2525 may limit the amount of tension the adjustmentmechanism 2524 creates in the connecting member 2521. As a connectingmember 2521 is drawn into the anchor 2501 by activation of theadjustment mechanism 2524, a tension in the connecting member 2521 mayincrease. The tension in the connecting member 2521 may be transferredto the skin through the anchor 2501 that has been adhered to the skin.It may be desirable to limit the amount of force applied to the skin,for example, to limit damage to the skin. The slip clutch 2525 may beset to a desired force limit setting. When the force limit is reached byan activation of the adjustment mechanism 2524, the slip clutch 2525 maybe activated. The slip clutch 2525 may prevent a tension in theconnecting member 2521 from exceeding the desired force limit.

An embodiment of a system including two or more anchors is illustratedin FIGS. 26 and 27. In an embodiment of a system shown in FIG. 26,anchors 2631, 2632, 2633, 2641, 2642, 2643 are placed on opposing sidesof an aperture 2 (e.g. a wound, surgical incision, or other aperture).The anchors 2631, 2632, 2633, 2641, 2642, 2643 may be connected by oneor more connecting members 2621. Each anchor 2631, 2632, 2633 may bepaired with an opposing anchor 2641, 2642, 2643 on an opposite side ofthe aperture 2. The pairs of opposing anchors may include one or moreanchors 2641, 2642, 2643 that may include adjustment mechanisms 2624(hereinafter referred to as adjustable anchors 2641, 2642, 2643) and oneor more anchors 2631, 2632, 2633 that do not include adjustmentmechanisms (hereinafter referred to as static anchors 2631, 2632, 2633).Opposing anchors may be connected via a single connecting member 2621,as shown, or may be connected via multiple connecting members 2621. Theconnecting members 2621 may span the aperture 2 FIG. 26 illustrates sixanchors 2631, 2632, 2633, 2641, 2642, 2643 arranged in three pairs. Eachadjustable anchor 2641, 2642, 2643 may be adjusted to draw in theconnecting member 2621 toward the anchor 2641, 2642, 2643, thusdecreasing the distance between a pair of anchors and drawing theaperture 2 toward a closed state. Each adjustable anchor 2641, 2642,2643 may be adjusted independently.

Another embodiment of a system of anchors is illustrated in FIG. 27. Inthis embodiment, two adjustable anchors 2741, 2742 and one static anchor2731 are adhered to the skin 1 of a patient on various sides of anasymmetrical aperture 2. A single connecting member 2721 may connect allthree anchors 2741, 2742, 2731. The connecting member 2721 may span theaperture 2. Each adjustable anchor 2741, 2742 may be adjustedindependently. Decreasing the distance between the anchors by activatingthe adjustment mechanism 2724 of the adjustable anchors 2741, 2742 maydraw the aperture 2 toward a closed state.

In another embodiment not shown, a single adjustable anchor and one ormore static anchors may be adhered to the skin of a patient. Forexample, the embodiment of the system illustrated in FIG. 26 may includeonly one adjustable anchor 2741 and a single connecting member 2721. Anadjustment of the adjustable anchor 2741 would cause every other anchor2731, 2742 to be drawn towards one another, thus relieving a stress inthe aperture 2 and drawing it closed. In other embodiments of anchorsystems, only two anchors may be adhered to the skin. Any number ofanchors may be adhered and connected in any number of configurations.One may appreciate from the embodiments described herein that numerousconfigurations of multiple anchor systems may be employed. The number ofanchors and their position on the skin of a patient may depend on theshape of the aperture 2 and the force required to close the aperture 2.Indeed, one of the advantages of one or more embodiments of the systemsherein described is the adaptability of the system in order to meet thevarious needs of different patients and apertures. For example, smallwounds may only require two opposing anchors, while larger wounds mayrequire many more. Anchors may be placed on opposing sides ofirregularly shaped wounds. A system of anchors may also be configured toclose multiple wounds simultaneously. One may appreciate from the abovedescription that nearly an infinite number of system configurations maybe employed.

Stitches, sutures, and staples may not be necessary to close an apertureusing the described tensioning anchors and systems. At least oneembodiment of the anchors described herein may leave no scars and/or maynot otherwise damage the skin of the patient. Once a wound has healedand the anchors are removed, the remaining portions of adhesivecomposition may slough off over time as the outer layer of skindesquamates.

The total force applied on the skin of a patient by a tensioning anchorsystem is divided by the total surface area of the multiple anchors incontact with the skin. Therefore, a large force may be applied to closean aperture with relatively small forces applied to the skin by eachindividual tensioning anchor.

IV. Adhesive Composition

As described, the barrier device can be utilized with an adhesive inorder to provide the static or stable retention of the medical devicewith respect to the incision as well as the inhibition or prevention ofinfections from entering the incision. A variety of adhesivecompositions can be used, such as those that are compatible with theskin that do not cause serious skin irritation. Also, the adhesivecomposition can be compatible with the barrier device and medical deviceso as to promote adhesion with limited damage or degradation of thestructural integrity thereof.

In one embodiment, the adhesive composition is any biocompatibleadhesive. As such, reference to an adhesive composition herein is anatural or synthetic substance that adheres to skin without substantialside effects or complications. Examples of such biocompatible adhesivecomposition (bioadhesives) are substantially non-toxic,non-inflammatory, and configured to adhere to the body of a medicaldevice and to skin. These types of adhesive compositions, contactadhesives, are commonly used in transdermal drug delivery devices. Also,these types of adhesive compositions are well known to those of ordinaryskill in the relevant arts.

In one embodiment, the bioadhesive is a polymer or monomer thatpolymerizes into a polymer that is configured to adhere to skin and tothe body of a medical device. For example, the polymer is biocompatibleand flexible. This allows for being directly applied to the skin at asite of insertion of a medical device, and allows the medical device theability to move with respect to the insertion site without breaking theadhesive bond.

In one embodiment, the bioadhesive is comprised of silicones, vinyls,polyethylenes, polyvinylchlorides, polyacrylates, polymethacrylates,polyisobutylenes, monomers thereof that form adhesive, and the likewhich are biocompatible.

In one embodiment, the bioadhesive is comprised of serum albumin andglutaraldehyde, such as BioGlue™.

In one embodiment, the bioadhesive is a composition that includes acyanoacrylate. Cyanoacrylates are compounds commonly used in theadhesive industry. For example, the cyanoacrylate can include amethyl-2-cyanoacrylate ethyl-2-cyanoacrylate (i.e., Superglue™ and KrazyGlue™), and 2-octyl cyanoacrylate or n-butyl-cyanoacrylate, which areused in medical glues (i.e., Dermabond™ and Traumaseal™), apolyacrylate, polycyanoacrylate, other cyanoacrylates, and combinationsthereof. Cyanoacrylate is a tenacious adhesive, particularly when usedto bond skin with a medical device, where the skin usually has minutetraces of water. In its liquid form, cyanoacrylate consists of monomersof cyanoacrylate molecules. Methyl-2-cyanoacrylate (CH₂═C(CN)COOCH₃ orC₅H₅NO₂) has a molecular weight equal to 111.1, a flashpoint of 79° C.,and 1.1 times the density of water. Ethyl-2-cyanoacrylate (C₆H₇NO₂) hasa molecular weight equal to 125 and a flashpoint of >75° C. Also, thecyanoacrylates are susceptible to fracture and loss of adhesiveness whenchilled to an appropriate temperature, which allows for the use ofchilling in order to remove the barrier device from the skin of asubject.

Generally, a cyanoacrylate is an acrylic resin which rapidly polymerizesin the presence of water, forming long, strong chains, joining thebonded surfaces together. Because the presence of moisture causes theglue to set, exposure to moisture in the air can cause a tube or bottleof glue to become unusable over time. To prevent an opened container ofglue from setting before use, it should be stored in an airtight jar orbottle, and optionally with a package of silica gel.

Cyanoacrylate sets quickly, often in less than a minute. A normal bondreaches full strength in two hours and is waterproof. Accelerators suchas toluidine trigger setting in two or three seconds, with some loss ofstrength.

The adhesive composition can be configured so as to produce and maintainstrong glue-skin, glue-barrier device, and glue-catheter adhesiveinterfaces. Such strong adhesive composition interfaces have been shownby adhering materials (e.g., polyurethanes, polyethylenes,polypropylenes, PVC, Teflon, and the like) that can be used in thebarrier device and medical device to skin with an adhesive in accordancewith the present disclosure. Thus, the adhesive and/or device of thepresent disclosure could be used as an antimicrobial barrier for mostcentral venous catheter sites of insertion, as well as other sites ofinsertions for other medical devices.

Alternatively, the cyanoacrylate can be substituted by anotherbioadhesive that is configured to adhere to skin and to the body of amedical device, such as a catheter. This is because certain polymers,which are bioadhesive, can create an occlusive barrier between the skinand a medical device, wherein the occlusive barrier is resistant topenetration by bacteria or other microbes. Applying these polymers atthe site of catheter entry or entry of other medical device through theskin prevent catheter-related infections by inhibiting microbes fromentering into the site of entry and colonizing at the percutaneous siteand/or on the catheter portion that is disposed within the skin.

Experiments can be utilized to determine whether a bioadhesive issuitable for the present disclosure. Suitable bioadhesives can beapplied to the skin and medical device at the site of insertion to forma barrier. The barrier can be visually inspected to insure the barrieris sufficient. For example, a histologic cross-section can be studied toensure the bioadhesive is sufficient. Additionally, the barrier can beexamined for barrier function by examining the movement of bacteriaafter being placed over the intact barrier, and evaluating forpenetrance of those bacteria beyond that barrier.

In one embodiment, one or more different types of adhesive compositionscan be used at various locations of the barrier device, skin, and/ormedical device. This can include one type of adhesive composition forthe base surface and a different adhesive composition for the perimeter.For example, a weaker adhesive composition can be used on the base whilea stronger adhesive composition can be used at the perimeter.

In one embodiment, the base surface can include a peelable liner thatprotects an adhesive composition disposed on the base surface such thatthe base surface can be adhered to the skin after the peelable liner isremoved. The adhesive composition on the base surface under the peelableliner can be any type of adhesive, such as pressure adhesives and thoseadhesive compositions used in transdermal devices. Thus, the base of thebarrier device can be applied to the skin similarly to a transdermaldevice. Moreover, a drug can be included in the adhesive on the basesurface so that the barrier device can be used as a transdermal drugdelivery device. This can include the use of anesthetics,antimicrobials, or the like being delivered to the skin under thebarrier device.

V. Kit

One or more components of the embodiments described herein may beprovided in a kit. For example, in one embodiment, the presentdisclosure includes a catheter kit that has a barrier device andadhesive, such as a cyanoacrylate, as described herein. The barrierdevice and/or adhesive can be configured to be placed at the catheterinsertion site as described so as to form a barrier with the skin andcatheter so that microbes are inhibited from entering the insertionsite. For example, the anti-microbial barrier formed from the barrierdevice and adhesive can be maintained when used on a percutaneouslyplaced central venous catheter.

In one embodiment, the present disclosure includes an adhesive (e.g.,cyanoacrylate) and barrier device that can be used together to form ananti-microbial barrier for an opening in skin where a medical deviceextends through. For example, the cyanoacrylate composition and/ordevice can be used as a mechanical and/or therapeutic barrier that hasantimicrobial properties. That is, the cyanoacrylate composition and/ordevice can physically prevent microbes from entering a medical deviceinsertion site and can effect antimicrobial properties.

In one embodiment, the present disclosure includes a wound closure kitthat has one or more anchors, one or more connecting members, and anadhesive composition, such as a cyanoacrylate, as described herein.Tensioning anchors, connecting members, and adhesive compositions may beconfigured around an aperture, such as a wound, surgical incision, orother aperture, in order to close it, thus aiding in the healingprocess. Alcohol pads, iodine swabs, surgical gloves, and other sanitaryequipment may also be included in the kit and utilized to minimizeinfection or wound exposure to bacteria before, during, and after theuse of a wound closure system. A syringe or other fluid injector mayalso be included in the kit. The syringe may be used to introduce afluid into an inner chamber of a bladder or anchor. This fluidintroduction may inflate the bladder or expandable membrane of two ormore anchors that have been adhered to skin.

VI. Application

In one embodiment, the present disclosure includes a method of using abarrier device in combination with an adhesive, such as those thatcontain a cyanoacrylate, in order to form an impermeable barrier againstbacteria at a percutaneous incision site for passing a medical deviceinto or through skin. As such, the device and adhesive are placed at theincision so as to contact the skin and barrier device so as to form abarrier. Also, the adhesive can be used to form barriers between thebarrier device and medical device as well as between the skin andmedical device in order to provide one or more barriers as described.The one or more barriers can retain the medical device in a staticposition relative to the skin and incision such that a barrier inhibitsbacteria from entering the incision. Bacteria tend to infect cathetersby contaminating the catheter at the site of the percutaneous incisionand subsequently traveling down the external surface of the catheter andinto the bloodstream. Thus, the one or more barriers formed with thebarrier device and adhesive can both provide a static medical deviceposition as well as provide a barrier that inhibits microbial infectionsin the incision.

In one embodiment, the barrier is formed from a flowable adhesivecomposition that hardens at a skin-barrier device interface,skin-medical device interface, and/or barrier device-medical deviceinterface. Such flowable adhesive compositions can be liquids, gels,pastes, and the like. The flowable composition can be placed onto theskin, barrier device, and medical device at an interface therebetween,which is usually at, adjacent, or proximal with the percutaneousincision. For example, an adhesive composition can be administered ontothe skin adjacent to a percutaneously inserted intravascular catheterand the barrier device can be applied to the adhesive so as to receivethe catheter therein so as to reduce the risk of developing acatheter-related infection. In another example, a fluid (e.g., liquid orpaste) adhesive is applied to the intersection between the skin and theperimeter of the barrier device so as to create a perimeter barriertherearound. In yet another example, the adhesive is applied to amedical device disposed in an incision, and the barrier device is slidor applied over the medical device so as to come into contact with theskin so that a barrier forms between the medical device and barrierdevice (and optionally to the skin) in the barrier device conduit. Instill yet another example, adhesive is applied to the barrier device atthe top opening from with the medical device protrudes to form a barrierwith the medical device. In another example, adhesive is applied to aclam-type barrier device that is then closed around the medical deviceand adhered to the skin. In yet another example, adhesive is applied toa groove and base surface of a barrier device and then the barrierdevice is applied to the medical device and skin such that the medicaldevice is adhered to the groove and the base surface is adhered to theskin.

In an embodiment of a barrier device, an adhesive composition may residein capsules disposed on the bottom surface of a barrier device. Thecapsules act as a barrier to the adhesive composition until the deviceis applied to a surface. When the barrier device is placed on a surface,a pressure may be applied to the top surface of the barrier device overthe capsules residing underneath. The capsules may rupture, becomeleaky, or otherwise fail under pressure, thus releasing the adhesivecomposition, adhering the barrier device to a surface, such as the skinof a patient.

In another embodiment, illustrated in FIGS. 18A and 18B, an adhesivecomposition may reside in a groove in a bottom surface of a barrierdevice. A seal may span the groove and seal the adhesive compositionwithin the groove. The adhesive composition and the seal may be placedon or in the bottom surface of the barrier device during themanufacturing of the barrier device. The seal may prevent the adhesivecomposition from being exposed to air, thus preventing polymerization,until the barrier device is adhered to a surface. The adhesivecomposition is free to make contact with the skin of a patient andadhere the barrier device to the skin upon removal of the seal. FIG. 18Billustrates an embodiment of a barrier device that includes aneasy-release seal. An easy-release seal may include a pull tab. A personremoving the seal may grab hold of the pull tab and pull the seal awayfrom and off of the barrier device. Once the seal is removed and theadhesive composition is exposed, there will be a window of time beforethe adhesive composition polymerizes. The barrier device may be adheredon the skin of a patient within this window of time. That is, after theremoval of the seal but prior to polymerization of the adhesivecomposition. Other methods of use are also contemplated.

In one embodiment, the barrier device and adhesive can be used toinhibit or prevent pistoning of the catheter within the incision.Pistoning can include slight movements, in and out, of the catheter thatcan introduce bacteria into the incision and catheter tract. Sutureshave been found to be insufficient to prevent pistoning; however, theuse of the barrier device and adhesive can effectively inhibitpistoning. Additionally, sutures form additional holes in the skin whichthemselves can lead to infection. The barrier device of the presentdisclosure can be used to inhibit slight pistoning. This can includeinhibiting pistoning that moves the medical device from about 0.5 mm toabout 10 mm into or out of the incision, from about 1 mm to about 5 mm,or about 2 mm to about 3 mm movements can be prevented. This can preventinfectious material from being introduced into the catheter line orother incision having a percutaneous medical device.

While some pistoning may occur during use of the device, the sterileenvironment around the incision and proximal portions of the medicaldevice provided by the barrier device can be maintained so thatinfections are not introduced into the incision. As such, the barrierdevice maintains sterility of the incision as proximal areas by virtueof the barriers that are formed by the barrier device and adhesivecombination. Accordingly, minor pistoning may occur, but substantiallyno microbes will be able to enter into and infect the incision.

In one embodiment, the present disclosure includes a method for removingthe adhesive-formed barrier and barrier device from the skin around oradjacent to the incision site between the skin and medical device. Sucha method can include applying a solvent to the adhesive so as to degradethe adhesive so that the barrier device can be removed from the skin.Solvents such as acetone or tetrahydrofuran, and the like can be used tosoften the cyanoacrylate adhesive. Solvents that soften through dissolvethe adhesives of the present disclosure are well known in the art.

Additionally, the adhesive can be cooled so as to cause the bond betweenthe skin, barrier device, and/or medical device to become brittle. Thiscan be accomplished by locally decreasing the temperature with acoolant, such as liquid nitrogen or other cooling fluid. For example,the cooling fluid can be applied to the external surfaces of theadhesive or through conduits to internal surfaces of the adhesive. Whenthe adhesive cools sufficiently, it can be easily cracked or broken inorder to remove the barrier device.

Also, an inflatable bladder can be disposed between the barrier deviceand adhesive such that inflation of the bladder causes the adhesivebarrier to break. This inflatable bladder can then be used to separatethe bond between the skin and the medical device and/or barrier deviceso that the medical device and/or barrier device can be removed from theskin. The bladder therefore uses hydraulic pressure to expand andmechanically break the bond of the barrier. A fluid may be introducedinto the inner chamber of the bladder through a port, such as a Luerlock connection. A syringe or other injection device may be used toinject the fluid through the port.

The barrier device may be configured such that an inner chamber isenclosed between top and bottom layers of the barrier device. The bottomlayer of the device may have thin walled expandable portions.Introduction of a fluid into the inner chamber of the device expands thethin walled portions of the bottom layer, causing the bond between thedevice and the adhesive composition to weaken. The thin walled portionsof the bottom layer of the device use hydraulic pressure to expand so asto mechanically break the bond of the barrier. A fluid may be introducedinto the inner chamber through a port, such as a Luer lock connection. Asyringe or other injection device can be used to inject the fluidthrough the port. Other methods of injecting fluid into the innerchamber may also be used. For example, a hypodermic needle may be usedto puncture the top or bottom layer of the barrier device and inject afluid into the inner chamber. The puncture hole, in this method, wouldbe the port through which the fluid is introduced.

Additionally, a release cord could be used in order to break the barrierbetween the barrier device and skin. For example, a release cordattached to the barrier device can be pulled so that it cuts theadhesive barrier and separates the barrier device from the skin. Such arelease cord can also separate the barrier device from the medicaldevice.

Of course, the skin, barrier device, and medical device can be sterileduring the use described herein. Also, the procedures described can beperformed in a manner that does not introduce or propagate infections.Additionally, sterilization techniques can be conducted to sterilize theskin, barrier device, and medical device before, during, and/or afterplacement of the catheter into an incision as well as placement of thebarrier device with respect to the medical device and skin.

In one embodiment, the present disclosure includes a method for applyinga system of anchors to a surface, such as the skin of a patient. Theanchors may be arranged adjacent to an aperture (e.g. surgical incision,wound, or other aperture). A flowable adhesive composition may beapplied to the anchors and/or to the skin where the anchors are to beplaced. Such flowable adhesive compositions can be liquids, gels,pastes, and the like. The flowable adhesive composition may be placedonto the skin, anchor, at an interface therebetween, or combinationsthereof. The anchor may be placed adjacent to an aperture. In oneexample, adhesive is applied to a base surface of an anchor and then theanchor is applied to the skin such that the anchor is adhered to theskin. In yet another example, the adhesive composition resides incapsules disposed on the bottom surface of the anchor or bladder. Thecapsules act as a barrier to the adhesive composition until the anchoris used. When the anchor is placed on a patient, a pressure may beapplied to the top surface of the anchor over the capsules residingunderneath. The capsules fail under pressure and release the adhesivecomposition, adhering the anchor to the patient.

In one embodiment, an adhesive composition resides in a groove in thebottom surface of the anchor. A seal may span the groove and seal theadhesive composition within the groove. The adhesive composition and theseal may be placed on or in the anchor during the manufacturing of theanchor. The seal prevents the adhesive composition from exposure to air,thus preventing polymerization, until the anchor is used. The adhesivecomposition is free to make contact with the skin of a patient andadhere the anchor to the skin upon removal of the seal. A pull tab maybe utilized to grab hold of the seal, which may then be removed bypulling it away from the anchor. Once the seal is removed and theadhesive composition is exposed, the adhesive composition will have awindow of time before it polymerizes. The anchor may be positioned onthe skin of a patient within this window of time. That is, after theremoval of the seal but prior to polymerization.

Once the adhesive composition has polymerized and adhered the anchors tothe skin, one or more connecting members may be secured to the anchorsvia the receiving members on the anchors. A connecting member may beconfigured to connect two or more anchors together. One may appreciate,from the description of multiple embodiments and configurations of woundclosure systems described herein, that any configuration of anchorpositions on the skin of a patient may be achieved.

In some embodiments, once the anchors and receiving members are inplace, an adjustment mechanism on one or more of the anchors may beactivated. An activation of the adjustment mechanism draws theconnecting member in toward the anchor, thus decreasing the distancebetween connected anchors. This may draw the skin on opposing sides of awound or incision closer together, thus relieving stress in the woundand potentially closing it. Once a desired closure has been achieved byadjusting the anchor or anchors, the adjustment mechanism on one or moreof the anchors may be locked so as to prevent the connecting member frombeing released out away from the anchor or anchors. The distance betweenconnected anchors will remain constant until the locking mechanism isunlocked and the connecting member may be drawn out away from one ormore of the anchors.

After a period of time, the connecting member may be readjusted tocontinue closing a wound. For example, the skin may stretch allowing forincreased tension to be applied to one or more connecting members (e.g.,via one or more adjustment mechanisms).

In one embodiment, the present disclosure includes a method for removingthe tensioning anchors from a surface, such as the skin of a patientaround or adjacent to an aperture. Such a method may include disposingan inflatable bladder between the anchor and adhesive composition suchthat inflation of the bladder results in a weakening of the bond betweenthe adhesive composition and the barrier device. The tensioning anchorsmay then be removed from the adhesive composition. Portions of theadhesive composition may remain on the skin of the patient and sloughoff over time as the outer layer of skin desquamates. A fluid may beintroduced into an inner chamber of the bladder through a port, such asa Luer lock connection. A syringe or other injection device may be usedto inject the fluid through the port. Other methods of injecting fluidinto the inner chamber may also be used. For example, a hypodermicneedle may be used to puncture the bladder wall and inject a fluid intothe inner chamber. The puncture hole, in this method, would be the portthrough which the fluid is introduced.

One or more anchors may be configured such that an inner chamber isenclosed by top and bottom layers of the base members of the anchors.The bottom layer of the anchors may have thin walled expandable regions.Introduction of a fluid into the inner chamber of the anchor may causean expansion of the thin walled portions of the bottom layer, weakeninga bond between the adhesive composition and the anchor. The thin walledportion of the bottom layer of the anchors uses hydraulic pressure toexpand and mechanically weaken the adhesive bond. Fluid may beintroduced into the inner chamber through a port, such as a Luer lockconnection. A syringe or other injection device may be used to injectthe fluid through the port.

Anchor systems and/or surfaces to which they may be applied may besterile during the use described herein. The procedures described may beperformed in a manner that does not introduce or propagate infections.Sterilization techniques may be conducted to sterilize the skin, barrierdevice, and anchors, during, and/or after placement of the barrierdevice and anchors on the skin of a patient.

The present disclosure may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope. All references (e.g.,journal articles, published patent applications, patents, websites, andthe like) that are recited herein are incorporated herein by specificreference in their entirety.

The articles “a,” “an,” and “the” are intended to mean that there areone or more of the elements in the preceding descriptions. The terms“comprising,” “including,” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements. Additionally, it should be understood that references to “oneembodiment” or “an embodiment” of the present disclosure are notintended to be interpreted as excluding the existence of additionalembodiments that also incorporate the recited features. For example, anyelement described in relation to an embodiment herein may be combinablewith any element of any other embodiment described herein. Numbers,percentages, ratios, or other values stated herein are intended toinclude that value, and also other values that are “about” or“approximately” the stated value, as would be appreciated by one ofordinary skill in the art encompassed by embodiments of the presentdisclosure. A stated value should therefore be interpreted broadlyenough to encompass values that are at least close enough to the statedvalue to perform a desired function or achieve a desired result. Thestated values include at least the variation to be expected in asuitable manufacturing or production process, and may include valuesthat are within 5%, within 1%, within 0.1%, or within 0.01% of a statedvalue.

A person having ordinary skill in the art should realize in view of thepresent disclosure that equivalent constructions do not depart from thespirit and scope of the present disclosure, and that various changes,substitutions, and alterations may be made to embodiments disclosedherein without departing from the spirit and scope of the presentdisclosure. Equivalent constructions, including functional“means-plus-function” clauses are intended to cover the structuresdescribed herein as performing the recited function, including bothstructural equivalents that operate in the same manner, and equivalentstructures that provide the same function. It is the express intentionof the applicant not to invoke means-plus-function or other functionalclaiming for any claim except for those in which the words ‘means for’appear together with an associated function. Each addition, deletion,and modification to the embodiments that falls within the meaning andscope of the claims is to be embraced by the claims.

It should be understood that any directions or reference frames in thepreceding description are merely relative directions or movements. Forexample, any references to “front” and “back” or “top” and “bottom” or“left” and “right” are merely descriptive of the relative position ormovement of the related elements.

1. A surface barrier device for creating a barrier around an aperture ina patient's skin, comprising: a top surface and a bottom surface,wherein the bottom surface is configured to make contact with said skin;a compliant portion; an enclosed inner chamber, wherein the innerchamber is at least partially enclosed by the complaint portion; anadhesive composition, wherein the adhesive composition is applied to thecompliant portion so as to adhere the compliant portion to said skin;and a port configured to receive a fluid into the inner chamber, thecompliant portion configured to expand upon receiving a fluid into theinner chamber, the expansion weakening a bond between the adhesivecomposition and the compliant portion.
 2. The surface barrier device ofclaim 1, wherein the compliant portion is a bladder disposed on thebottom surface of the surface barrier device, the enclosed inner chamberresiding within the bladder;
 3. The surface barrier device of claim 1,wherein the compliant portion is a bladder disposed around the perimeteredges of the surface barrier device, the enclosed inner chamber residingwithin the bladder;
 4. The surface barrier device of claim 1, whereinthe adhesive composition is a cyanoacrylate.
 5. The surface barrierdevice of claim 1, wherein the port comprises a Luer lock connection. 6.The surface barrier device of claim 1, wherein a pressure sensitiveadhesive composition is disposed on the bottom surface of the barrierdevice medial to the compliant portion.
 7. The surface barrier device ofclaim 1, wherein a pressure sensitive adhesive composition is disposedon the bottom surface of the barrier device lateral to the compliantportion.
 8. The surface barrier device of claim 1, wherein the portincludes a one-way valve.
 9. The surface barrier device of claim 1,further comprising a top layer and a bottom layer, wherein the innerchamber is enclosed between the top and bottom layers, a bottom surfaceof the bottom layer making contact with said skin, the bottom layercomprising one or more compliant portions.
 10. The surface barrierdevice of claim 9, wherein the bottom layer is comprised of a materialwith a thickness, the compliant portions of the bottom layer having areduced thickness.
 11. The surface barrier device of claim 1, whereinthe adhesive composition is enclosed in a plurality of capsules disposedon the bottom surface of the device, wherein the adhesive composition isreleased from the capsules and polymerizes, adhering the surface barrierdevice to the surface, when a pressure is applied to the capsules. 12.The surface barrier device of claim 1, further comprising: a seal, theseal covering and sealing the adhesive composition, wherein a rupture orremoval of the seal exposes the adhesive composition, the adhesivecomposition polymerizing upon exposure.
 13. The surface barrier deviceof claim 1, further comprising an absorbent material disposed on thebottom surface of the device, the absorbent material located generallymedial to the adhesive composition, wherein the absorbent material isconfigured to absorb excess fluids located on the surface and underneaththe barrier device.
 14. A method for removing the surface barrier deviceof claim 1 that has been adhered to a patient having skin using anadhesive composition, the method comprising: injecting a fluid into theinner chamber; and expanding the compliant portion, the expansionweakening a bond between the compliant portion and the adhesivecomposition.
 15. The method of claim 14 further comprising exerting aforce on the barrier device to detach the barrier device from theadhesive composition, wherein a portion of the adhesive compositionremains on the skin of the patient.
 16. A method for providing a barrieron a surface, comprising: providing a surface barrier device, thesurface barrier device comprising: a top surface and a bottom surface,wherein the bottom surface is configured to make contact with a surface;a compliant portion; an enclosed inner chamber, wherein the innerchamber is at least partially enclosed by the complaint portion; a portconfigured to receive a fluid into the inner chamber; applying anadhesive composition to a surface contacting region of the compliantportion to adhere the compliant portion to a surface; and securing thesurface barrier device onto the surface, wherein the adhesivecomposition polymerizes, adhering the surface barrier device to thesurface, the compliant portion configured to expand upon receiving afluid into the inner chamber, the expansion weakening a bond between theadhesive composition and the compliant portion.
 17. The method of claim16, further comprising providing a pressure sensitive adhesive on thebottom surface of the surface barrier device.
 18. A kit for providing awound barrier comprising: a surface barrier device, the surface barrierdevice comprising: a top surface and a bottom surface, wherein thebottom surface is configured to make contact with a surface; a compliantportion; an enclosed inner chamber, wherein the inner chamber is atleast partially enclosed by the complaint portion; an adhesivecomposition, wherein the adhesive composition is applied to thecompliant portion so as to adhere the compliant portion to a surface;and a port configured to receive a fluid into the inner chamber, thecompliant portion configured to expand upon receiving a fluid into theinner chamber, the expansion weakening a bond between the adhesivecomposition and the compliant portion; an adhesive composition; and asyringe and or other injector for injecting a fluid.
 19. The kit for ofclaim 18, further comprising a surface disinfecting fluid and/or tool.20-39. (canceled)